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

Model Number	A35HPV08040080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	02/12/2020
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
During index procedure, a medtronic pta balloon was used to treat the venous outflow in the left arm.Approximately 23 months post procedure, patient suffered stenosis in the avf which was treated using a non-medtronic pta balloon.Patient recovered.Investigator and sponsor assessed event is not related to device, procedure or paclitaxel.

• 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: 9858976
• Report Number: 2183870-2020-00089
• Device Sequence Number: 14183333
• Product Code: LIT
• UDI-Device Identifier: 00821684057667
• UDI-Public: 00821684057667
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 03/20/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2020
• Device Model Number: A35HPV08040080
• Device Catalogue Number: A35HPV08040080
• Device Lot Number: A542693
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 03/20/2020
• 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 Age: 56 YR