MAUDE Adverse Event Report: MERIL LIFE SCIENCES PVT. LTD. MOZECTM NC RX PTCA 2.5.00MM X 30MM; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	MNC25015
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pursuant to the fda code of federal regulations, (b)(4) is an importer of mozectm nc rx balloon dilatation catheters, a distributed product made by meril.Therefore, cordis is required to report all complaints of deaths and serious injuries to the fda associated with this product.
Event or Problem Description
As reported, after opening the blockage and deflating the balloon, resistance was felt during removal of the mozectm balloon catheter (nc rx ptca 2.5.00 mm x 30 mm).The doctor felt the balloon catheter jump back and, after removal, found that the device came apart at the rx port and the distal part of the balloon was still in the patient.The doctor attempted removal using a non-cordis device unsuccessfully.The doctor ended up trapping the separated piece using an unknown balloon and was able to remove the separated section.The procedure started as a total heart catheterization but turned into an intervention to the distal right coronary artery (rca).The rca was described as heavily calcified and tortuous.The target artery was initially accessed using a non-cordis guide catheter, a non-cordis guidewire and a non-cordis guide extension.The procedure was finished successfully with six elunir stents being implanted.There was no patient injury reported.The device was clinically used and will be returned for analysis.The device was not resterilized.No anomalies were noted when removed from the package.No anomalies were noted during prep.The device was not inserted through a stopcock instead of a hemostatic valve.Resistance was not met while advancing the device.Excessive torquing was not required.Resistance was not met while advancing the device over the guidewire.The device did not kink or bend at any time prior to the resistance/friction.The other devices used with the product did not kink or bend at any time.The device did not kink in the area of separation.The device separated at the rx port.The balloon used to retrieve the separated section was a non-cordis device.Returned product analysis: the concomitant device, mozec nc - rx ptca balloon dilatation catheter was returned for analysis.The device was returned in two separate pieces, which confirmed the reported separation near the rx port.The balloon body was reviewed and no issues were noted.A visual examination of the tip showed no signs of damage.The balloon wings were relaxed indicating that the balloon was subjected to positive pressure (inflated and deflated).Visible blood traces in lumen and balloon body were noted during analysis.Blood traces were also noted in the intermediate shaft and the luer hub.A visual and tactile examination of the catheter revealed multiple kinks along the catheter length on proximal shaft.The catheter was also found to be bent near the intermediate shaft.The outer diameter was measured on each end of the fracture on the catheter shaft and found to be within the specification.Thus the fracture did not occur due to linear stresses or tensile overload.The profile of the break point is indicative of a torsional fracture suggesting kinking or twisting prior to separation.Based on the observations noted above, the probable root cause of the device malfunction appears to be use of excessive force used to overcome resistance experienced during the procedure.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The manufacturing batch record review confirmed that the device met all specifications.
Additional Manufacturer Narrative
As reported, after opening the blockage and deflating the balloon, resistance was felt during removal of the 2.5x30mm mozec nc rx percutaneous transluminal coronary angioplasty (ptca) balloon catheter.The doctor felt the balloon catheter jump back and, after removal, found that the device came apart at the rx port and the distal part of the balloon was still in the patient.The doctor attempted removal using a non-cordis device unsuccessfully.The doctor ended up trapping the separated piece using a competitor balloon and was able to remove the separated section.The procedure started as a total heart catheterization but turned into an intervention to the distal right coronary artery (rca).The rca was described as heavily calcified and tortuous.The target artery was initially accessed using a non-cordis guide catheter, a non-cordis guidewire and a non-cordis guide extension.The procedure was finished successfully with six elunir stents being implanted.There was no patient injury reported.The device was not resterilized.No anomalies were noted when removed from the package.No anomalies were noted during prep.The device was not inserted through a stopcock instead of a hemostatic valve.Resistance was not met while advancing the device.Excessive torqueing was not required.Resistance was not met while advancing the device over the guidewire.The device did not kink or bend at any time prior to the resistance/friction.The other devices used with the product did not kink or bend at any time.The device did not kink in the area of separation.The device separated at the rx port.The balloon used to retrieve the separated section was a non-cordis device.The concomitant device, mozec nc - rx ptca balloon dilatation catheter was returned for analysis.The device was returned in two separate pieces, which confirmed the reported separation near the rx port.The balloon body was reviewed and no issues were noted.A visual examination of the tip showed no signs of damage.The balloon wings were relaxed indicating that the balloon was subjected to positive pressure (inflated & deflated).Visible blood traces in lumen and balloon body were noted during analysis.Blood traces were also noted in the intermediate shaft and the luer hub.A visual and tactile examination of the catheter revealed multiple kinks along the catheter length on proximal shaft.The catheter was also found to be bent near the intermediate shaft.The outer diameter was measured on each end of the fracture on the catheter shaft and found to be within the specification.Thus, the fracture did not occur due to linear stresses or tensile overload.The profile of the break point is indicative of a torsional fracture, suggesting kinking or twisting prior to separation.A review of the lot history record for mnch26 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The manufacturing batch record review confirmed that the device met all specifications.The reported ¿body/shaft separated - in-patient¿ and ¿pta/ptca system withdrawal difficulty¿ were confirmed through analysis of the returned device.The exact cause of the failure experienced could not be determined during analysis.However, based on the information available for review and the product analysis, the probable root cause of the device malfunction appears to be the use of excessive force applied to overcome resistance experienced during the withdrawal of the device as evidenced by the torsional fracture.Moreover, as reported, the procedure was expected to have complications due to the "tough, heavily calcified tortuous artery." according to the instructions for use, which is not intended as a mitigation, ¿prior to angioplasty, examine the ptca catheter to verify functionality.Ensure that its size and shape are suitable for the specific procedure for which it is to be used.When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated under vacuum.If resistance is felt during manipulation, determine the cause of the resistance before proceeding.Caution: care should be taken when inserting the ptca catheter into the haemostatic valve in order to avoid kinking.Determine the correct position of the balloon catheter under fluoroscopy using radiopaque markers as a guide.If resistance is encountered during advancement, do not force passage.Determine the cause of resistance and take corrective actions.Apply negative pressure to the inflation device to achieve complete deflation of the balloon.Confirm the balloon is completely deflated under fluoroscopy.Loosen the haemostatic valve to facilitate removal of the balloon catheter.While holding the guide wire and the haemostatic valve with one hand, gradually remove the balloon catheter from the guide catheter.Withdraw the ptca catheter till the guide wire exit port is exposed.Slide the remainder of the ptca catheter along the guide wire until the tip of the ptca catheter exits the haemostatic valve.¿ based on the available information, there is no evidence to suggest that the event was design or manufacturing related.Neither the dhr review nor the returned product analysis suggests that the reported failures could be related to the manufacturing process.Therefore no corrective or preventive action will be taken at this time.

• Brand Name: MOZECTM NC RX PTCA 2.5.00MM X 30MM
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MERIL LIFE SCIENCES PVT. LTD.; bilakhia house, survey no. 135; muktanand marg; chala, vapi 39619 1; IN 396191
• MDR Report Key: 7829221
• Report Number: 1016427-2018-01755
• Device Sequence Number: 1175822
• Product Code: LOX
• UDI-Device Identifier: 18906029358223
• UDI-Public: 18906029358223
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2018
• Report Date (Section F): 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2020
• Device Model Number: MNC25015
• Device Catalogue Number: MNC25015
• Device Lot Number: MNCH26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IKARI GC,PILOT GW,GUIDEZILLA EXT,6 ELUNIR STENTS
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 08/22/2018