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

Catalog Number A35HPV07040080

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2019

Event Type  malfunction  

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 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
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9069021
• MDR Text Key: 194678672
• Report Number: 2183870-2019-00450
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00763000106102
• UDI-Public: 00763000106102
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K142654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1