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

Catalog Number	A35HPV10040080
Medical Device Problem Codes	Burst Container or Vessel (1074); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that a physician was attempting to use a fortrex balloon with an non-medtronic 7fr (terumo) sheath and non medtronic 0.035x180 stiff angled guidewire to treat a lesion in a patient in the distal left arm fistula.No damage noted to packaging, i.E.Shelf carton, hoop/tray, no issues noted when removing the device from the hoop/tray, device was prepped per the ifu.It was reported that a balloon burst occurred during inflation at 18 atms, and 4 inflations.Removal difficulties were also experienced removing balloon following balloon inflation.Device did not pass through a previously-deployed stent, resistance was not encountered when advancing the device, excessive force was not used.The balloon was removed with sheath and replaced the (terumo) sheath with 7f 23cm (cordials) sheath to complete the procedure.No patient injury reported for this event.
Additional Manufacturer Narrative
Product analysis: 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.The fortrex was received with only 33mm proximal balloon chamber material remaining bonded to the catheter.The balloon chamber material exhibited radial/circumferential tearing.Not all of the 40mm length balloon chamber material was returned.The distal inner guidewire lumen exhibited tensile stretching.The distal end of the inner guidewire lumen did not contain either the distal marker band or distal tip.The pouch was checked for any additional components.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 8377272
• Report Number: 2183870-2019-00100
• Device Sequence Number: 2926594
• Product Code: LIT
• UDI-Device Identifier: 00821684057810
• UDI-Public: 00821684057810
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/06/2021
• Device Catalogue Number: A35HPV10040080
• Device Lot Number: A641390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR