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

Catalog Number A35HPV12080080

Device Problem Burst Container or Vessel (1074)

Patient Problems Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)

Event Date 12/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: month and year valid.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a fistulogram, a fortrex device burst.The patient had a venotomy to remove the fragments of balloon but this was unsuccessful.The patient was admitted to hospital and taken for a repeat fistulogram the next day.The fragments from the fortrex balloon were in the subclavian vein near the proximal stent.A stent was used to cage the fragments to the patient's vessel wall.

Manufacturer Narrative

Additional information: burst occurred during balloon inflation in the great saphenous vein (gsv).If information is provided in the future, a supplemental report will be issued.

• Brand Name: FORTREX 0.035 OTW PTA BALLOON CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8339230
• MDR Text Key: 136144296
• Report Number: 2183870-2019-00073
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00763000106430
• UDI-Public: 00763000106430
• 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: other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2021
• Device Catalogue Number: A35HPV12080080
• Device Lot Number: A744172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2019
• Initial Date FDA Received: 02/14/2019
• Supplement Dates Manufacturer Received: 02/22/2019
• Supplement Dates FDA Received: 02/28/2019
• Date Device Manufactured: 11/25/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR