MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX P3 F5 8X4 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 4208040S

Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/13/2022

Event Type  Injury  

Manufacturer Narrative

This device is available for analysis, but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt. Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the balloon of an 8mm x 4cm 80cm powerflex p3 percutaneous transluminal angioplasty (pta) balloon catheter ruptured while ballooning a tight lesion within a fistula. The rupture caused the balloon to separate into two pieces and a portion of the balloon was left inside the patient upon removal of the powerflex p3 pta balloon catheter. The left-over portion of the balloon was eventually removed from the patient; however, there was a lot of bleeding, and an unknown covered stent was placed. The patient is now discharged. The device prepped normally and was able to maintain negative pressure. There wasn¿t any difficulty removing the stylet or any of the sterile packaging components and there were no kinks or other damages noted prior to inserting the product into the patient. There was no calcification at the target site, but mild tortuosity was present in the target vessel. The balloon was not being used to post dilate a previously placed stent. Information regarding the removal of the separated balloon segment, contrast media, contrast to saline ratio, inflation pressure, covered stent implantation, bleeding, and possible vessel damage was requested but is unavailable. The device will be returned for evaluation.

• Brand Name: POWERFLEX P3 F5 8X4 80
• 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: 13513707
• MDR Text Key: 287558905
• Report Number: 9616099-2022-05339
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 4208040S
• Device Lot Number: 82206888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2020
• 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: 02/11/2022 Patient Sequence Number: 1

Treatment

UNKNOWN COVERED STENT