MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX P3 F5 12X4 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4202040S

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Event Description

As reported, the balloon of a 12mm x 4cm 80cm powerflex p3. 035 percutaneous transluminal angioplasty (pta) balloon catheter was unable to be inflated and a leak was observed at the distal balloon tip. There was no reported injury to the patient. Additional information was requested but is unavailable, and the device will not be returned for evaluation.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: POWERFLEX P3 F5 12X4 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: 14073278
• MDR Text Key: 290097116
• Report Number: 9616099-2022-05535
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 4202040S
• Device Catalogue Number: 4202040S
• Device Lot Number: 82227796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 08/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial