MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 6MM6CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	N/A
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The report received from the affiliate indicated the 6mm x 6cm 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter (bc) was torn.There was no patient injury.The product was returned for analysis.One non-sterile powerflex pro 6mm x 6cm 135cm balloon catheter was returned.Per visual analysis, the balloon was completely ruptured from proximal to distal areas of balloon.Blood residues were present on the unit.No other anomalies were noted.Per sem analysis the balloon internal surface and marker bands did not reveal any evidence of damage or defect.However, the external surface revealed evidence of scratch marks adjacent to the balloon ruptured areas and it is very likely that the same factors that caused the scratch marks on the balloon outer surface contributed to the ruptured condition found.No other anomalies were found during the analysis.A product history record (phr) review of lot 17651369 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ and ¿balloon frayed/ split/torn¿ were confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.Based on the information available for review, vessel characteristics (although unknown) may have contributed to the burst and torn condition as evidenced by scratch marks noted on the outer surface during analysis.According to the safety information in the instructions for use ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.Balloon pressure should not exceed the rated burst pressure.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence), will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over pressurization.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate the balloon.Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.
Event or Problem Description
The report received from the affiliate indicated the 6mm6cm 135 powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was torn.Analysis of the returned device indicates balloon burst.There was no patient injury.

• Brand Name: POWERFLEXPRO 6MM6CM 135
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8256927
• Report Number: 9616099-2019-02643
• Device Sequence Number: 16652838
• Product Code: LIT
• UDI-Device Identifier: 20705032059548
• UDI-Public: 20705032059548
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/17/2019

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: 02/29/2020
• Device Model Number: N/A
• Device Catalogue Number: 4400606X
• Device Lot Number: 17651369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1