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

Model Number A35HPV06040080

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354)

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

Event Date 10/17/2021

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 fortrex pta balloon catheter along with non-medtronic 6fr sheath and 0.035" guidewire during procedure to treat the right arm autogenous arteriovenous fistula vein stenosis.Lesion stenosis about 80%.Ifu was followed a non-medtronic inflation device was used for the inflation of the balloon.There was no damage noted to packaging.There was no issue noted when removing the device from hoop/tray.The device was prepped per ifu.It was reported that balloon inflation difficulties occurred at 15atm.The device did not pass through a previously deployed stent.There was no resistance encountered when advancing the device.After the balloon was put into the patient's blood vessel, the stenosis balloon was pressurized to 15atm and the balloon ruptured.Rupture occurred on first inflation.Pinhole burst occurred.The balloon did not fragment.All of the balloon removed.No vessel injury noted.Device was safely removed from patient.No intervention required for removal.After that, a new balloon was replaced with, and the lesion was expanded to complete the procedure.There was no patient injury.

Manufacturer Narrative

Product analysis: the fortrex pta balloon device was returned to medtronic investigation lab for evaluation.The device was returned coiled inside a plastic pouch.The fortrex balloon catheter was received with a longitudinal tear in the balloon chamber.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
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12702997
• MDR Text Key: 278585653
• Report Number: 2183870-2021-00392
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00763000105983
• UDI-Public: 00763000105983
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K142654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2023
• Device Model Number: A35HPV06040080
• Device Catalogue Number: A35HPV06040080
• Device Lot Number: B115002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2022
• Date Device Manufactured: 11/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female