MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 10MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	4401004S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A 10mm x 4cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was used for preparation; however, it ruptured due to severe calcification.No patient injury was reported.The lesion was the iliac artery.A non-cordis guidewire crossed the lesion.The powerflex pro was replaced with a new, non-cordis balloon catheter and the procedure was completed.The patient had no infectious disease.The product was not returned for analysis.A product history record (phr) review of lot 82153089 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.With the limited information available and without return of the product for analysis, it is difficult to draw a clinical conclusion between the device and the reported event.However, vessel characteristics of severe calcification may have contributed to the reported event, as it is known that calcium may damage balloon material.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 nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
Event or Problem Description
As reported, a 10x4 powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was used for preparation, however it ruptured due to severe calcification.No patient injury was reported.The lesion was the iliac artery.A non-cordis guidewire crossed the lesion.The powerflex pro was replaced with a new, non-cordis balloon catheter and the procedure was completed.The patient had no infectious disease however the device was discarded in the hospital.

• Brand Name: POWERFLEXPRO 10MM4CM 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8748322
• Report Number: 9616099-2019-03048
• Device Sequence Number: 11273353
• Product Code: LIT
• UDI-Device Identifier: 20705032060056
• UDI-Public: 20705032060056
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2019

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: 03/31/2021
• Device Catalogue Number: 4401004S
• Device Lot Number: 82153089
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 07/01/2019
• 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: GUIDEWIRE (VASSALLO NS, FILMEC); UNKNOWN BALLOON CATHETER