MAUDE Adverse Event Report: CREGANNA MEDICAL ALSO D/B/A CREGANNA-TACTX MEDICAL EMPIRA NC RX PTCA POST-DILATATION CATHETER; PTCA CATHETER

Model Number 75R12400N

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Calcium Deposits/Calcification (1758); Chest Pain (1776); Stenosis (2263); Ischemic Heart Disease (2493); No Code Available (3191)

Event Date 08/12/2016

Event Type  Injury  

Event Description

The physician post dilated a stent in the proximal rca at 30atm for 122 seconds.The ptca would then not deflate.They tried to bring a buddy wire and a guideliner catheter to take out the balloon from the proximal rca.That didn't work, so the patient ended up having an emergency bypass.

Manufacturer Narrative

The complaint reported that "the physician post dilated a stent in the proximal rca at 30atm for 122 seconds.The ptca would then not deflate.They tried to bring a buddy wire and a guideliner catheter to take out the balloon from the proximal rca.That didn't work, so the patient ended up having an emergency bypass." as of 20 september 2016, when the complaint analysis was completed, no additional information was received.Product was not returned for review at the time of this report being completed.The device is not available for investigation and examination.It was therefore not possible to carry out any dimensional, functional, visual or microscopic examination on the device.Therefore the as reported classification of system balloon - deflation difficulty cannot be confirmed.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 not any capa, (corrective and preventative action), mrr (material review report) or deviation being generated for this lot, unknown during the manufacturing process that may have contributed to the reported issue.The similar complaint trend review could not be executed since the lot number of the device was not received.Was it used per ifu? the complaint stated that the balloon was inflated to 30 atm.Per the instructions for use section v, the balloon pressure should not exceed the rated burst pressure.The rated burst pressure for the empira nc rx ptca post-dilatation catheter is 20 atm.Therefore, as the rbp was exceeded, the device was used off label.The complaint reported has been assigned a primary as reported classification of balloon - deflation difficulty.Following completion of creganna medical information review, the primary as analysed classification has been assigned.Empira - product not returned.Complaint unable to confirm and the secondary as analysed classification has been assigned empira n/a.The most probable root cause with rationale product was not returned for review at the time of this report being completed.The device is not available for investigation and examination.It was therefore not possible to carry out any dimensional, functional, visual or microscopic examination on the device.Therefore the as reported classification of system balloon; deflation difficulty cannot be confirmed.The complaint stated that the balloon was inflated to 30 atm.Per the instructions for use section v, the balloon pressure should not exceed the rated burst pressure.The rated burst pressure for the empira nc rx ptca post-dilatation catheter is 20 atm.Therefore, as the rbp was exceeded, the device was used off label and the root cause of this complaint has been classified? user/use error'.The probable root-cause classification assigned to this complaint is 'user/use error'.The definition of 'user/use error' is: ' confirmed through complaint investigation that there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.' based on the above conclusion, no further escalation or corrective action is required at this time.We will continue to monitor for these complaint types.Not returned to manufacturer.

Event Description

The physician post dilated a stent in the proximal rca at 30atm for 122 seconds.The ptca would then not deflate.They tried to bring a buddy wire and a guideliner catheter to take out the balloon from the proximal rca.That didn't work, so the patient ended up having an emergency bypass.

Manufacturer Narrative

Additional information received as of 14 december 2016, when the complaint was re-opened, the cordis clinician report on the images reviewed was received; following the review of all 54 images contained in the cd the sequence of events appears as follows: firstly the diagnostic sequence indicates moderate to severe disease of the right coronary artery (rca) with lesions in the distal, mid and proximal rca.The vessel, and lesions in particular, appear to be heavily calcified with some flow reduction.The ostial rca would indicate this was a large diameter vessel prior to the disease process.The left coronary arteries showed a left anterior descending artery (lad) in good condition, with good flow, and a diffusely diseased circumflex artery (cx) with scant flow and an indication of distal collateralization to or from the distal rca illuminated by late filling at the end of the runs.For the interventional procedure, after cannulation, the vessel was double wired to protect the posterior descending artery (pda) and the distal rca.A stent was placed directly in the distal rca and after one wire was pulled back, it was deployed successfully.Post dilation gave an excellent result with good flow.A stent was then placed directly in the proximal portion and deployed successfully.However the lesion between the right ventricular branch and the sinoatrial nodal branch encroached into the lumen creating a filling defect.A balloon was placed for post-dilation and inflated numerous times, up to a reported 30 atmospheres, without effect on what appears to be a very resistant lesion.At this point the flow distal to the stent became reduced, the stent appeared to possibly be fractured and the calcified lesion appeared to be cracked.Thrombogenesis occurred distal to the stent, with an almost total reduction in flow, and the operator appeared to have difficulty removing the balloon.The balloon appeared to be deflated at this point.The guiding catheter was aggressively cannulated into the vessel to help capture the balloon, without success.A [?]buddy' guide wire was reinserted but this failed to release the balloon.The final sequence shows a lack of flow, a large filling defect at the culprit lesion and a balloon within the proximal portion of the proximal stent.The likely scenario is the balloon became stuck on the unknown fractured stent and could not be removed, resulting in emergency coronary artery bypass surgery and surgical removal of the balloon.This received additional information does not change the conclusions of the initial complaint analysis.The complaint reported that "the physician post dilated a stent in the proximal rca at 30 atm for 122 seconds.The ptca would then not deflate.They tried to bring a buddy wire and a guideliner catheter to take out the balloon from the proximal rca.That didn't work, so the patient ended up having an emergency bypass." as of 20 september 2016, when the complaint analysis was completed, no additional information was received.Product analysis review product was not returned for review at the time of this report being completed.The device is not available for investigation and examination.It was therefore not possible to carry out any dimensional, functional, visual or microscopic examination on the device.Therefore the as reported classification of system balloon - deflation difficulty cannot be confirmed.A review of risk management documentation 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.A review of the manufacturing documentation there was not any capa, (corrective and preventative action), mrr (material review report) or deviation being generated for this lot, unknown during the manufacturing process that may have contributed to the reported issue.Statement on trend data (lot only) the similar complaint trend review could not be executed since the lot number of the device was not received.Was it used per ifu? the complaint stated that the balloon was inflated to 30 atm.Per the instructions for use section v, the balloon pressure should not exceed the rated burst pressure.The rated burst pressure for the empira nc rx ptca post-dilatation catheter is 20 atm.Therefore, as the rbp was exceeded, the device was used off label.As reported / as analysed classification the complaint reported has been assigned a primary as reported classification of balloon - deflation difficulty.Following completion of creganna medical information review, the primary as analysed classification has been assigned empira - product not returned - complaint unable to confirm and the secondary as analysed classification has been assigned empira - n/a.The most probable root cause with rationale product was not returned for review at the time of this report being completed.The device is not available for investigation and examination.It was therefore not possible to carry out any dimensional, functional, visual or microscopic examination on the device.Therefore the as reported classification of system balloon - deflation difficulty cannot be confirmed.The complaint stated that the balloon was inflated to 30 atm.Per the instructions for use section v, the balloon pressure should not exceed the rated burst pressure.The rated burst pressure for the empira nc rx ptca post-dilatation catheter is 20 atm.Therefore, as the rbp was exceeded, the device was used off label and the root cause of this complaint has been classified 'user/use error'.The probable root-cause classification assigned to this complaint is [?]user/use error'.The definition of 'user/use error' per csop0058 rev 09 is: ' confirmed through complaint investigation that there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.' if further escalation is required 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.Not returned to manufacturer.

Event Description

The physician post dilated a stent in the proximal rca at 30 atm for 122 seconds.The ptca would then not deflate.They tried to bring a buddy wire and a guideliner catheter to take out the balloon from the proximal rca.That didn't work, so the patient ended up having an emergency bypass.

Manufacturer Narrative

The complaint reported that "the physician post dilated a stent in the proximal rca at 30atm for 122 seconds.The ptca would then not deflate.They tried to bring a buddy wire and a guideliner catheter to take out the balloon from the proximal rca.That didn't work, so the patient ended up having an emergency bypass." as of 20 september 2016, when the complaint analysis was completed, no additional information was received.As of 14 december 2016, when the complaint was re-opened, the cordis clinician report on the images reviewed was received; following the review of all (b)(4) images contained in the cd, the sequence of events appears as follows: firstly the diagnostic sequence indicates moderate to severe disease of the right coronary artery (rca) with lesions in the distal, mid and proximal rca.The vessel, and lesions in particular, appear to be heavily calcified with some flow reduction.The ostial rca would indicate this was a large diameter vessel prior to the disease process.The left coronary arteries showed a left anterior descending artery (lad) in good condition, with good flow, and a diffusely diseased circumflex artery (cx) with scant flow and an indication of distal collateralization to or from the distal rca illuminated by late filling at the end of the runs.For the interventional procedure, after cannulation, the vessel was double wired to protect the posterior descending artery (pda) and the distal rca.A stent was placed directly in the distal rca and after one wire was pulled back, it was deployed successfully.Post dilation gave an excellent result with good flow.A stent was then placed directly in the proximal portion and deployed successfully.However the lesion between the right ventricular branch and the sinoatrial nodal branch encroached into the lumen creating a filling defect.A balloon was placed for post-dilation and inflated numerous times, up to a reported 30 atmospheres, without effect on what appears to be a very resistant lesion.At this point the flow distal to the stent became reduced, the stent appeared to possibly be fractured and the calcified lesion appeared to be cracked.Thrombogenesis occurred distal to the stent, with an almost total reduction in flow, and the operator appeared to have difficulty removing the balloon.The balloon appeared to be deflated at this point.The guiding catheter was aggressively cannulated into the vessel to help capture the balloon, without success.A [?]buddy' guide wire was reinserted but this failed to release the balloon.The final sequence shows a lack of flow, a large filling defect at the culprit lesion and a balloon within the proximal portion of the proximal stent.The likely scenario is the balloon became stuck on the unknown fractured stent and could not be removed, resulting in emergency coronary artery bypass surgery and surgical removal of the balloon.This received additional information does not change the conclusions of the initial complaint analysis.As of 13 january 2017, the complaint was re-opened again, as the device did return for investigation.Product analysis review: based on the investigation conducted the complaint (balloon - deflation difficulty and balloon - removal difficulty) could be confirmed.The noted damage (balloon burst and tip damage) does correspond with the as reported classifications.A review of risk management documentation: 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.A review of the manufacturing documentation: there was not any capa, (corrective and preventative action), mrr (material review report) or deviation being generated for this lot, unknown during the manufacturing process that may have contributed to the reported issue.Statement on trend data (lot only): the similar complaint trend review could not be executed since the lot number of the device was not received.Was it used per ifu? the complaint stated that the balloon was inflated to 30 atm.Per the instructions for use section v, the balloon pressure should not exceed the rated burst pressure.The rated burst pressure for the empira nc rx ptca post-dilatation catheter is 20 atm.Therefore, as the rbp was exceeded, the device was used off label.As reported / as analysed classification: the complaint reported has been assigned a primary as reported classification of balloon - deflation difficulty.Following completion of creganna medical information review, the primary as analysed classification has been assigned empira - empira - balloon - burst and the secondary as analysed classification has been assigned empira - tip - damage.The most probable root cause with rationale: based on the investigation conducted the complaint (balloon - deflation difficulty and balloon - removal difficulty) could be confirmed.The noted damage (balloon burst and tip damage) does correspond with the as reported classifications.The complaint stated that the balloon was inflated to 30 atm.Per the instructions for use section v, the balloon pressure should not exceed the rated burst pressure.The rated burst pressure for the empira nc rx ptca post-dilatation catheter is 20 atm.Therefore, as the rbp was exceeded, the device was used off label and the root cause of this complaint has been classified 'user/use error'.The probable root-cause classification assigned to this complaint is 'user/use error'.The definition of 'user/use error' per csop0058 rev 09 is: ' confirmed through complaint investigation that there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.' if further escalation is required based on the above conclusion, no further escalation or corrective action is required at this time.We will continue to monitor for these complaint types.

Event Description

The physician post dilated a stent in the proximal rca at 30atm for 122 seconds.The ptca would then not deflate.They tried to bring a buddy wire and a guideliner catheter to take out the balloon from the proximal rca.That didn't work, so the patient ended up having an emergency bypass.

• Brand Name: EMPIRA NC RX PTCA POST-DILATATION CATHETER
• Type of Device: PTCA CATHETER
• Manufacturer (Section D): CREGANNA MEDICAL ALSO D/B/A CREGANNA-TACTX MEDICAL; 1353 dell ave; campbell; ca 95008 95008
• Manufacturer (Section G): CREGANNA MEDICAL ALSO D/B/A CREGANNA-TACTX MEDICAL; 1353 dell ave; campbell; ca 95008
• Manufacturer Contact: orla hickey ; 1353 dell ave; california; ca 95008 ; 0035391757
• MDR Report Key: 5916834
• MDR Text Key: 53548494
• Report Number: 3004036480-2016-00002
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 75R12400N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention