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

Catalog Number	A35HPV12040080
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician used a fortrex balloon to treat a severely calcified lesion with cto (chronic total occlusion 100%) in a distal arteriovenous fistula.Lesion length and diameter were 50mm and 12 mm, respectively.Ifu was followed and device was prepped without issues.A non-medtronic inflation device was used.The device passed through a previously deployed stent and severe resistance was felt during withdrawal and excessive force was used.It was reported that the balloon burst occurred below rated burst pressure (rbp).Pressure.The physician tried to withdraw but felt that something got stuck and then forced the balloon to pull out with little bit of power.Afterwards, the balloon split by three pieces.The procedure was completed using another hp balloon.
Additional Manufacturer Narrative
Additional information received: balloon burst occurred at approximately 4-5 atm.All fragments were retrieved.This resulted in injury to the avf.The device was not returned for evaluation.The customer provided two photos of the damaged fortrex.Both photos were similar showing the damaged components from approximately the same angle and focal point.The photos provided show the fortrex separated into three separate pieces.The pieces included the catheter shaft, manifold assembly and distal balloon segment of the catheter.The catheter shaft and distal balloon segment showed traces of blood throughout.The catheter shaft in the photo was evaluated and the proximal marker band was observed.The distal fracture occurred distal to the proximal marker band.The proximal fracture face of the catheter shaft was flat and rounded.The photo of the manifold assembly showed no damage or anomalies to the manifold however, the catheter shaft was fractured distal to the strain relief of the manifold assembly.The fracture face showed rounded edges and appeared flat.The distal balloon segment showed the balloon had a radial fracture.The distal tip and distal end of the balloon found no damage, however the balloon showed signs of buckling and showed blood within the balloon.There was no visibility though the balloon where the blood was identified.The catheter shaft exposed beneath the balloon showed buckling.The fracture face of the distal segment was ductile.It should be noted the distal marker band was not identified, but the visualization of the marker band was likely blocked from the balloon filled with biologics/blood.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: FORTREX 0.035 OTW PTA BALLOON CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8137467
• Report Number: 2183870-2018-00566
• Device Sequence Number: 13889577
• Product Code: LIT
• UDI-Device Identifier: 00821684057872
• UDI-Public: 00821684057872
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K142654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/14/2021
• Device Catalogue Number: A35HPV12040080
• Device Lot Number: A693245
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 12/06/2018; 02/28/2019
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 12/19/2018; 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other