MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 5MM4CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number N/A

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

The product history review is expected but has not been completed.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a 5mm x 4cm x 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was used as pre-dilation; but it ruptured at 6 atmospheres.Therefore, it was replaced with another unknown device and the procedure continued.There was no reported patient injury.The target lesion was the superficial femoral artery (sfa) which had severe calcification.A contralateral approach was made.The device will not be returned for evaluation as it was discarded.As of note, this complaint was reported late because it was difficult for the sales rep to meet the physician.

Manufacturer Narrative

Complaint conclusion: as reported, a 5mm x 4cm x 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was used as pre-dilation; but it ruptured at six atmospheres.Therefore, it was replaced with another unknown device and the procedure continued.There was no reported patient injury.The target lesion was the superficial femoral artery (sfa) which had severe calcification.A contralateral approach was made.The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 82187284 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst - at/below rbp¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of severe calcification may have contributed to the reported event.However, with the limited amount of information provided and without the return of the device for analysis, it is difficult to draw a clinical conclusion between the device and the event reported.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 or preventive action will be taken at this time.

• Brand Name: POWERFLEXPRO 5MM4CM 135
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10934829
• MDR Text Key: 219199805
• Report Number: 9616099-2020-04094
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032059333
• UDI-Public: 20705032059333
• Combination Product (y/n): N
• PMA/PMN Number: K112797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 4400504X
• Device Lot Number: 82187284
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK OTHER DEVICE; UNK OTHER DEVICE