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

Catalog Number A35HPV10080080

Device Problem Burst Container or Vessel (1074)

Patient Problems Hemorrhage/Bleeding (1888); Patient Problem/Medical Problem (2688)

Event Date 08/30/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician attempted to use a fortrex balloon with a non-medtronic 7 fr sheath for the treatment of a non-calcified, fibrous fistulae in the right arm. The lesion presented little tortuosity and 60% stenosis. Artery diameter is 10 cm. The device was prepped as per the ifu with no issues identified. The balloon was not passed through a previously deployed stent. There was no resistance encountered on advancement. A medtronic inflation device was used for balloon inflation. It was reported that a circumferential/radial balloon burst occurred during inflation at 18atm. An incision had to be performed on the fistulae to retrieve the balloon fragments from the vasculature. All balloon fragments were removed from the patient. It is also reported that the patient had hemorrhage/bleeding in the access site.

Manufacturer Narrative

Product analysis: the fortrex was returned for evaluation. A 7 f sheath was returned as well. No other ancillary devices were included. The fortrex was loaded inside the introducer. Dried blood was observed throughout the returned devices. A radial balloon burst was identified. The catheter fractured at the distal end between the marker bands into two segments. The approximate length of the proximal segment of the catheter was 78cm. The distal edge of the fracture face of the proximal segment showed ductile fracture (photo 9). The balloon burst was radial and the proximal marker band was identified within the balloon segment. The distal segment of the balloon burst/catheter fracture was inspected. The balloon material was compressed/buckled. After stretching out the balloon material the distal segment of the catheter was identified. The distal segment of the blue catheter was identified. The distal marker band was identified on the catheter. No marker band dislodgment identified. The fractured off distal piece of the balloon showed the balloon material bunched up and the distal portion of the catheter was included. The distal marker band was identified after stretching out the balloon material. The proximal segment of the returned device showed a ductile fracture face consistent was exposed to excessive tensile fo rces. The proximal marker band was identified within the balloon. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the balloon burst occurred on the first inflation. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: no treatment required for access site bleeding/hemorrhage. 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: 8964071
• MDR Text Key: 156571364
• Report Number: 2183870-2019-00428
• Device Sequence Number: 1
• Product Code: LIT
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: A35HPV10080080
• Device Lot Number: A861251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 09/05/2019 Patient Sequence Number: 1