MAUDE Adverse Event Report: COVIDIEN FORTREX 0.035 OTW PTA BALLOON CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Model Number A35HPV08100080

Device Problem Burst Container or Vessel (1074)

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

Event Date 05/23/2022

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that a physician was attempting to use a fortrex balloon to treat a lesion in the patient¿s fistula.No damage was noted to packaging, device was prepped as per ifu.It was reported that the during balloon inflation, the balloon burst lower the recommended rate.The balloon did not pass through a previously deployed stent, resistance was not encountered, and no excessive force was used.The procedure was completed with a new balloon.No complications occurred due to this event.No patient injury reported for this event.

• Brand Name: FORTREX 0.035 OTW PTA BALLOON CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14510177
• MDR Text Key: 292722375
• Report Number: 2183870-2022-00184
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00763000106256
• UDI-Public: 00763000106256
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A35HPV08100080
• Device Catalogue Number: A35HPV08100080
• Device Lot Number: B365123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2022
• Date Device Manufactured: 04/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1