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	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/16/2018
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
It was reported that the physician used a fortrex balloon with a non-medtronic 7 fr sheath and.035 guidewire for treatment of a 25mm av fistula lesion.Embolic protection was not used.The ifu was followed.The device was prepped without issue.An inflation device was used for balloon inflation.It is reported that during inflation to 10 atmospheres, the balloon ruptured in the patient¿s vessel.An ensnare device was used to try and remove the device but this was unsuccessful.The patient was sent to a hospital for supraventricular tachycardia (svt) and a consult to remove the ruptured balloon.The balloon fragment was not removed from the patient.The patient was discharged from the hospital and is doing fine.
Additional Manufacturer Narrative
Evaluation summary: the fortrex 0.035in otw pta balloon catheter was received for evaluation.No ancillary devices or cine images from the procedure were received for evaluation.Approximately 72cm of the 80cm working length high-pressure balloon catheter was received.Approximately 8cm of the balloon catheter was not returned.Included in the 8cm not returned is 40mm of balloon chamber along with two radiopaque marker bands and the distal tip.The catheter separation was noted to have happened within the multilumen portion of the dilatation catheter.The catheter separation face exhibited tensile and torsional stretching.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: 7591926
• Report Number: 2183870-2018-00330
• Device Sequence Number: 275247
• Product Code: LIT
• UDI-Device Identifier: 00821684057872
• UDI-Public: 00821684057872
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K142654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 04/22/2021
• Device Catalogue Number: A35HPV12040080
• Device Lot Number: A634625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 06/12/2018; 08/08/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 07/09/2018; 10/03/2018
• 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: Required Intervention
• Patient Weight: 81