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

Catalog Number	A35HPV07040080
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fortrex balloon was returned.No ancillary devices were returned.The fortrex was inspected and the balloon showed signs of the previous inflation.The balloon was expanded.No damages or anomalies were observed.An inflation device filled with water was connected to the balloon inflation port after being loaded over a guidewire.The balloon was able to inflate to 12 atm; however, the balloon pressure could not be maintained.It was discovered a spray of water was coming out of a hole to the catheter shaft approximately 0.2 cm distal the strain relief.Under microscope the hole was longitudinal, consistent with possible contact/penetration of a sharp instrument.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician intended to use a fortrex pta balloon to treat a fistula.There was no damage noted to the packaging and there were no issues noted when removing the device from the tray/hoop.The device was prepped without issue.The device did not pass through a previously deployed stent, no resistance was encountered nor excessive force used on advancing the device tothe target lesion.The device was inflated but, on first inflation and at 0atm, a leak was observed at the luer/hub.Another pta was use to complete the procedure.No patient injury was reported.

• 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: 9069021
• Report Number: 2183870-2019-00450
• Device Sequence Number: 2477786
• Product Code: LIT
• UDI-Device Identifier: 00763000106102
• UDI-Public: 00763000106102
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2019

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: 02/26/2022
• Device Catalogue Number: A35HPV07040080
• Device Lot Number: A789967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1