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

Model Number A35HPV06040080

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/20/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was attempting to use a fortrex pta balloon catheter during procedure to treat the cephalic vein in the right arm.It was reported that the balloon lumen leaked, and the pressurized saline would flow out through the guide wire lumen.After the balloon was delivered into the stenosis of the blood vessel through the guide wire, the pressure of the balloon could not be added after it was connected to the pressure pump.After the balloon was pulled out and tested in vitro, it was found that the balloon lumen leaked, and the pressurized saline would flow out through the guide wire lumen.There was vessel stenosis at the puncture site.There was no resistance when the balloon was fed into the stenosis through the guidewire.Device was safely removed from patient.Physician replaced with a set of balloon of the same specification, opened up the lesion, and successfully completed the procedure.There was no patient injury.

Manufacturer Narrative

Image review one photograph and one video clip were provided by the customer for evaluation.The photograph shows the fortrex pta balloon in vitro, connected to an indeflator.The balloon is inflated with biologics visible inside the balloon profile and liquid exiting the tip of the device via the guidewire lumen.A screenshot of the video provided at 0:08 seconds shows the same image as the photo received with the balloon inflated with blood inside and liquid exiting the tip.A screenshot of the video provided at 0:46 seconds shows a second attempt at inflating the balloon using an indeflator and liquid exiting the distal tip during inflation.Device evaluation the balloon returned in its post inflated state.Visual inspection under a microscope shows both balloon marker bands intact and no deformation noted to the balloon.A 20ml water filled syringe connected to the device and flushed with no issues.A 0.035¿ guidewire from the lab was front loaded via the distal tip and exited out the gw port of the luer with no difficulty.The device was connected to an indeflator and pressure gauge and an attempt was made to inflate the balloon however water was noted immediately exiting the gw port of the luer.Bubbles were noted inside the balloon, indicating a leak in the balloon lumen.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
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 12437733
• MDR Text Key: 270327237
• Report Number: 2183870-2021-00323
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00763000105983
• UDI-Public: 00763000105983
• Combination Product (y/n): N
• PMA/PMN Number: K142654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: A35HPV06040080
• Device Catalogue Number: A35HPV06040080
• Device Lot Number: B094777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 55