This follow-up1 mdr is to give an update on the investigation findings by creganna medical in relation to this event as follows: correction: b1: report type updated to 'adverse event'.H1: type of reportable event updated to 'serious injury'.As of 06 july 2020, additional information was received on 26 may 2020: as our sales feedback that the balloon is completely separated from the delivery shaft (image 1 and 2).The balloon's body is removed from patient's body by surgery.As of on (b)(6) 2020, when the complaint analysis was completed, the following additional information was received; 1.There was no patient information available such as: age; weight; gender.2.The intended of the procedure was the distal end of the right coronary.3.The target lesion was the distal end of the right coronary.4.The following vessel / lesion characteristics were available: a.The lesion calcified (severe, moderate, little or none, unknown) yes b.There was no vessel tortuosity (severe, moderate, little or none, unknown).C.The percentage of stenosis was 80%.D.The device was no used for a chronic total occlusion (total occlusion 3 months).5.The product was stored and handled per instructions for use (ifu).6.There was no damage noted to the product packaging upon inspection prior to use.7.Was there any reported difficulty removing the product from the packaging? no 8.There was no difficulty removing the product from the hoop.9.There was no difficulty removing the protective balloon cover.10.The shipping stylet and balloon cover were removed after submerging in heparinized saline solution.11.There was no difficulty removing the stylet or any of the sterile packaging components.12.The product was inspected prior to use and appear to be normal.13.There were no kinks or other damages noted prior to inserting the product into the patient.14.The product was prepped properly according to the ifu.15.The device did prep normally (i.E.Maintain negative pressure).16.The brand and manufacturer of the contrast media used is unknown.17.The contrast to saline ratio is unknown.18.The type and brand of inflation device was used (indeflator/syringe) was merit.19.The same indeflator was used successfully with other devices.20.There was no resistance / friction while inserting the balloon through the rotating hemostatic valve.21.There was no resistance / friction while inserting the balloon through the guide catheter.22.There was no difficulty advancing the balloon catheter through the vessel.23.There was no difficulty crossing the lesion.24.The catheter was not in an acute bend.25.The user was able to depress the plunger into the syringe/indeflator when trying to inflate.26.The product was removed intact (in one piece) from the patient.27.To complete the procedure after the reported product issue another product was used.28.There was no intervention required as the balloon burst inside the patient.29.The patient condition after procedure is normal.30.The procedure was completed successfully without patient injury.31.The device will be returned for evaluation.(device was received on 17-jun-2020).32.There is no other additional information currently available.After review of additional information received on 11th june 2020, confirmation was requested for the following, however feedback was not received yet (as of 09jul2020): 26.The product was removed intact (in one piece) from the patient.28.There was no intervention required as the balloon burst inside the patient.30.The procedure was completed successfully without patient injury.The observations made during the analysis found the following: 1.The balloon cover was not returned with the product.2.The stylet was not present when the product was returned for investigation.3.There were three major kinks observed on the catheter at 610mm, 855mm and 975mm (from the distal) on the hypotube.4.There was evidence the balloon had been prepared and inflated.5.There was stretching damage noted on the distal tip.6.The balloon was separated from the delivery shaft potentially caused by the burst at the proximal bond area.7.There was no damage observed on the balloon.8.The proximal marker band was in its original place 9.The distal marker band was moved from inner member and was noted inside the distal side of the balloon.Based on a review of the risk documentation and information available, no updates are required to the risk documentation for the empira device.There is no indication of a potential processing or design failure associated with this complaint.There was no capa, (corrective and preventative action), mrr (material review report) or deviation being generated for this lot#: ce1021717 during the manufacturing process that may have contributed to the reported issue.Further, review of the manufacturing documentation for lot#: ce1021717 was completed and found that the device met its material, assembly and product specifications at the time of release to distribution.The review of the router and subsequent sub assembly routers did not highlight any anomalies.As of 06 july 2020, when the review was completed, there was no other complaint associated with lot number: ce1021717, for the as reported failure empira balloon separated.Information printed on the inner and carton labels are accurate.As per received additional information 'the shipping stylet and balloon were cover removed after submerging in heparinized saline solution.' per ifu the stylet and balloon cover are removed before submerging in heparinized saline solution: "10.Gently remove the shipping stylet along with the balloon cover from the catheter.Do not use the product if greater than normal resistance is met during the removal of the shipping stylet and/or balloon cover from the catheter.11.Insert the flushing needle into the distal tip of the ptca catheter and flush the guidewire lumen of the catheter with sterile heparinized saline solution by gently applying pressure with the syringe for 10 seconds.Remove the syringe with flushing needle.12.Submerge the catheter in sterile heparinized saline solution to activate the hydrophilic coating." image 3,4 and 5 shows balloon separated from the delivery shaft at the proximal bond site therefore, the in-process set tensile graphs, qc lot release tensile graphs for proximal bond and balloon burst qc lot release testing of lot#: ce1022717 were reviewed and did not highlight any anomalies.Based on the investigation conducted the complaint ( empira, balloon, separated) could be confirmed.Based on current available information review, the primary as analysed classification has been assigned empira, balloon, separated with a secondary as analysed classification empira, hypotube, kinks.Based on a full review of available information the probable investigation conclusion code assigned to this complaint is 'conclusion not yet available' defined as 'the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event'.A clinical review has been requested for complaint: (b)(4).The complaint report will be re-open when feedback received.If additional information is received at a later date, this will be reviewed, and the report will be updated accordingly in case it changes the conclusions.The compliant is reportable.Upon review of the above information, escalation has been made to quality management team.Based on the above conclusion, no further escalation or corrective action is required at this time.Creganna medical will continue to monitor for these complaint types.
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This follow-up 2 mdr is to give an update on the investigation findings by creganna medical in relation to this event due to additional information received to creganna medical as follows; additional information was received on 13 july 2020.From cardinal health received on 13 july 2020: see additional information requested below as a separation did not occur and the complaint will no longer be considered a serious injury by cordis.Please note that cordis has completed the clinical investigation of this complaint and do not expect any additional information.The device was returned to cordis and is on route to creganna, if not already received.Please complete the product report once the device analysis is complete.If additional information is received any at a later date, this information will be forward at that time.And further information received on 13 jul 2020: as our sales rep's feedback, the balloon was not separated from the delivery shaft and was removed intact from the patient.No intervention was required.Additional information received on 20 jul 2020.We have re-confirmed with sales that: when did this separation occur? - the balloon is completely separated from the delivery shaft.The balloon's body is removed from patient's body by surgery.Did this separation occur then during shipping? - no, during the operation the body of balloon was separated from the delivery shaft.Can we please clarify this so that the case file clearly depicts this separation did not occur in the patient.- the separation occurring in the patient.We apologized for the confusion this may have caused.Case detail report (b)(4) description summary was updated and received on 30 jul 2020: during a distal end of the right coronary procedure, the balloon of a 10mm x 3.5mm empira non-complaint (nc) rapid exchange (rx) percutaneous transluminal coronary angioplasty (ptca) balloon catheter burst when it hits 16 atmospheres and it completely separated from the delivery shaft.The balloon's body was removed from the patient by surgery.At the time of the procedure, the target lesion is calcified with eighty percent stenosis.The device was stored, handled, and prepped per the instruction for use (ifu).There were no damages noted to the product packaging upon inspection prior to use.There were no difficulties removing the product from the package, the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.The shipping stylet and balloon cover were removed after submerging in heparinized saline solution.A competitor's contrast media and inflation device was used.The inflation device was successfully used with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve, the guide catheter, or through the vessel.There was no difficulty crossing the lesion.The catheter has never been in an acute bend.There was no difficulty tracking towards the lesion.Images are available for review.The device is expected to be returned for evaluation.No other information was provided.Note: the additional information received on 11 june 2020 and 13-jul 2020 conflicts by stating the balloon did not burst in the body and was not required to be surgical removed from the patient.Subsequent additional information received on 20 jul 2020 when additional clarification was requested from the distributor.They confirmed the balloon catheter did burst at 16atm, during procedure post lesion been partially treated, the separation of the balloon happened inside the patient.As of 06 july 2020, when the complaint analysis was completed, the following additional information was received; on 11 june 20202: 1.There was no patient information available such as: age; weight; gender.2.The intended of the procedure was the distal end of the right coronary.3.The target lesion was the distal end of the right coronary.4.The following vessel / lesion characteristics were available: a.The lesion calcified (severe, moderate, little or none, unknown) -yes b.There was no vessel tortuosity (severe, moderate, little or none, unknown).C.The percentage of stenosis was 80%.D.The device was no used for a chronic total occlusion (total occlusion >3 months).5.The product was stored and handled per instructions for use (ifu).6.There was no damage noted to the product packaging upon inspection prior to use.7.Was there any reported difficulty removing the product from the packaging? -no 8.There was no difficulty removing the product from the hoop.9.There was no difficulty removing the protective balloon cover.10.The shipping stylet and balloon cover were removed after submerging in heparinized saline solution.11.There was no difficulty removing the stylet or any of the sterile packaging components.12.The product was inspected prior to use and appear to be normal.13.There were no kinks or other damages noted prior to inserting the product into the patient.14.The product was prepped properly according to the ifu.15.The device did prep normally (i.E.Maintain negative pressure).16.The brand and manufacturer of the contrast media used is unknown.17.The contrast to saline ratio is unknown.18.The type and brand of inflation device was used (indeflator/syringe) was merit.19.The same indeflator was used successfully with other devices.20.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.21.There was no resistance/friction while inserting the balloon through the guide catheter.22.There was no difficulty advancing the balloon catheter through the vessel.23.There was no difficulty crossing the lesion.24.The catheter was not in an acute bend.25.The user was able to depress the plunger into the syringe/indeflator when trying to inflate.26.The product was removed intact (in one piece) from the patient.27.To complete the procedure after the reported product issue another product was used.28.There was no intervention required.29.The patient condition after procedure is normal.30.The procedure was completed successfully without patient injury.31.The device will be returned for evaluation.32.There is no other additional information currently available.After review of additional information received on 11th june 2020, confirmation was requested for the following, 26.Was the product removed intact (in one piece) from the patient? -yes.28.Was there any intervention required - as the balloon burst inside the patient? -no.30.Was the procedure completed successfully without patient injury? -yes.As of 11 august 2020, based on the information received on 20 jul 2020, 26.Was the product removed intact (in one piece) from the patient? no - balloon separation was confirmed.28.Was there any intervention required - as the balloon burst inside the patient? - yes - balloon was surgical removed from the patient.30.Was the procedure completed successfully without patient injury? - unknown, no additional information received about current patient condition.Point 14 of the additional information has been corrected: 14.Additional information states that the product was prepped properly according to the ifu however, based on point 10 the shipping stylet and balloon cover were removed after submerging in heparinized saline solution.Per ifu instruction the stylet and balloon cover are removed before submerging in heparinized saline solution therefore the device was not prepped according to the ifu instructions.A clinical review was requested for complaint (b)(4) on 10 august 2020.A review of the complaint and event description was completed by creganna medical clinician on 11 august 2020 and include in the complaint report.The following additional information was requested on 27 july 2020; however, the feedback has not been received yet as of 12- aug-2020: is it possible to get 3mensio, ct scan in relation to this event? is there any chance to get this from hospital? if additional information is received at a later date, this will be reviewed, and the report will be updated accordingly in case it changes the conclusions.Investigation findings: the primary as analysed classification has been assigned empira - balloon - separated and a secondary as analysed classification of empira - balloon - burst-at/below rbp.The observations made during the analysis found the following: 1.The balloon cover was not returned with the product.2.The stylet was not present when the product was returned for investigation.3.There were three major kinks observed on the catheter at 610mm, 855mm, and 975mm (from the distal) on the hypotube.4.There was evidence the balloon had been prepared and inflated.5.There was stretching damage noted on the distal tip.6.The balloon was separated from the delivery shaft potentially caused by the burst at the proximal bond area.7.There was no damage observed on the balloon.8.The proximal marker band was in its original place.9.The distal marker band was moved from the inner member and was noted inside the distal side of the balloon.10.The inner member was separated (potentially during withdrawal attempts) causing the distal markerband to dislodge and remain in balloon body.Based on the investigation conducted the complaint (empira - balloon - separated) could be confirmed.During the analysis of the returned device, it was observed that the balloon was separated from the delivery shaft potentially caused by the burst on the shaft at the proximal bond area.While there is no evidence of a balloon burst the complaint is confirmed as there was a burst in the catheter system.Based on current available information review, the primary as analysed classification has been assigned empira - balloon - separated with a secondary as analysed classification empira - hypotube - kinks.There was no capa, (corrective and preventative action), mrr (material review report), or deviation being generated for this lot# ce1021717 during the manufacturing process that may have contributed to the reported issue.Further, a review of the manufacturing documentation for lot# ce1021717 was completed and found that the device met its material, assembly, and product specifications at the time of release to distribution.The review of the router and subsequent sub-assembly routers did not highlight any anomalies.As 11 august 2020, when the review was completed, there was no other complaint associated with lot number ce1021717, for the as reported failure empira - balloon - separated.As of 11 august 2020, when the review was completed, there was no other complaint associated with lot number ce1021717, for the as reported failure empira - balloon - burst-at/below rbp.Information printed on the inner and carton labels are accurate.As per the additional information received on 11-jun-2020 'the shipping stylet and balloon were cover removed after submerging in heparinized saline solution.' per ifu the stylet and balloon cover are removed before submerging in heparinized saline solution: "10.Gently remove the shipping stylet along with the balloon cover from the catheter.Do not use the product if greater than normal resistance is met during the removal of the shipping stylet and/or balloon cover from the catheter.11.Insert the flushing needle into the distal tip of the ptca catheter and flush the guidewire lumen of the catheter with sterile heparinized saline solution by gently applying pressure with the syringe for 10 seconds.Remove the syringe with flushing needle.12.Submerge the catheter in sterile heparinized saline solution to activate the hydrophilic coating." note: visual examination of the return device did not show evidence that removing shipping stylet and balloon cover after (not before as per ifu) submerging in heparinized saline solution led to any issues in the procedure.Image 3,4 and 5 show burst and balloon separation from the delivery shaft at the proximal bond site, therefore, the in-process set tensile graphs, qc lot release tensile graphs for the proximal bond, and balloon burst qc lot release testing of lot#ce1022717 were reviewed and did not highlight any anomalies.A review of the complaint and event description was completed by creganna medical clinician."it is my understanding that during an attempted pci of a calcified distal rca stenosis, the balloon ruptured at 16 atm and upon withdrawal of the device, the balloon itself was not attached to the shaft and was retained in the patient requiring surgical removal.It is most likely that the calcium in this lesion was responsible for the initial balloon rupture.This is known to occur under these circumstances and cannot be anticipated based on angiographic findings.Although the initial rupture may have been relatively small, it results in the inability to fully deflate the balloon.Since the lesion was likely at least partially treated, this may have exposed even more calcium to the lumen and therefore would have presented a roughened surface to the partially deflated balloon resulting in areas where the balloon could "snag" and therefore be further disrupted.It is likely that this occurred and as the operator attempted to withdraw the device, the balloon material was tethered on this and with even normal force of withdrawal caused the balloon to separate from the shaft.Therefore, i think the category of "operation context" most accurately characterizes this event.'' the additional information received, described the patient's anatomy that at the time of procedure the target lesion was calcified with eighty percent stenosis.The observed during analysis of return device shaft burst, and balloon separation most likely happened due to the patient's pre-existing anatomy condition.Therefore, based on all information available, returned device analysis, and patient medical conditions at the time of this procedure the most probable root-cause classification assigned to this complaint is 'operational context'.Defined as 'the complaint is associated with a product that meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure performance was limited.' following a review of the risk documentation and information available, no updates are required to the risk documentation for the empira nc rx ptca post-dilatation catheter device.There is no indication of a potential processing or design failure associated with this complaint.The compliant is deemed reportable.Upon review of the above information, escalation is required to the quality management team.Based on the above conclusion, no further escalation or corrective action is required at this time.Creganna medical will continue to monitor for these complaint types.
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