MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 8MM8CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4400808X

Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint. It is unknown if the device will be returned for testing and evaluation.    additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, after the powerflex pro 8mm8cm 135 balloon catheter was removed from the packaging, it was found that the delivery system at the head-end of the balloon was seriously kinked and split but not yet separated. There was no reported patient injury. The intended procedure was a limb artery balloon angioplasty. The lesion was moderately calcified. There was no vessel tortuosity. The percentage of stenosis was 70%. The device was used for a chronic total occlusion (total occlusion >3 months). The product was received in this condition. The product was stored properly according to the instructions for use (ifu). There was no damage noted to the product packaging upon inspection prior to use. There was no reported difficulty removing the product from the packaging. There was no damage noted to the box, pouch or hoop. The procedure was completed with another unknown balloon. The product is expected to be returned for evaluation.

• Brand Name: POWERFLEXPRO 8MM8CM 135
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13017900
• MDR Text Key: 285842623
• Report Number: 9616099-2021-05199
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K112797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 4400808X
• Device Catalogue Number: 4400808X
• Device Lot Number: 82200845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/16/2021 Patient Sequence Number: 1

Treatment

UNK BALLOON