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

Model Number	A35HPV06040080
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was attempting to use a fortrex pta balloon during procedure.It was reported that the balloon entered the stenotic lesion through the guide wire.The first time the pressure pump was used to pressurize, the pressure could not be pressurized, and the pressure leaked.After the balloon was pulled out, it was found that the balloon leaked after being pressurized.The insertion site was treated with iodophor for skin disinfection prior to product placement.The leak was noted at the connection between the balloon and the shaft.There was a small water column flowing out of the leak.The device was safely removed from the patient.Physician replaced with medtronic balloon of the same model and completed the operation.There was no patient injury.
Additional Manufacturer Narrative
Device evaluation the balloon returned in its post inflated state with biologics visible on the balloon profile.Visual inspection under a microscope shows both marker bands are intact.A 20ml water filled syringe was used to flush the device and a 0.035¿ guidewire was loaded through the tip and exited the inflation port of the hub without any difficulty.An indeflator with pressure gauge was used to inflate the balloon, but no pressure could be maintained, and the balloon exhibited a leak at the proximal end of the balloon.A microscopic inspection of the balloon revealed a tear just proximal to the proximal marker band where the leak is located.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
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 12437761
• Report Number: 2183870-2021-00324
• Device Sequence Number: 3655444
• Product Code: LIT
• UDI-Device Identifier: 00763000105983
• UDI-Public: 00763000105983
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K142654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2021

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: 10/14/2023
• Device Model Number: A35HPV06040080
• Device Catalogue Number: A35HPV06040080
• Device Lot Number: B102122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Initial Date Received by Manufacturer: 08/21/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 45