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

Model Number	A35HPV06100080
Medical Device Problem Codes	Inflation Problem (1310); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Image review: the customer returned one image.The image appears to show inflated balloon in a patient¿s vasculature.The middle of the balloon is not inflated which could indicate a twist in the balloon.However, this is a hypothesis and cannot be positively determined.The 2 balloon marker bands are visible in the image also.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician attempted to use an fortrex hp pta balloon catheter during patient treatment.There was no damage noted to packaging, i.E.Shelf carton, hoop/tray.No issues were noted when removing the device from the hoop/tray.Ifu was followed and the device was prepped without issue.An inflation device was used for balloon inflation.The device did not pass through a previously deployed stent.No resistance was noted during advancement.It is reported balloon inflation difficulties occurred when device was inflated to nominal burst pressure.There was no leak noted in the device.The balloon did not burst.The device was safely removed from the patient.A new fortrex device was used to complete the procedure.No patient injury reported.

• 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
• 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: 13003890
• Report Number: 2183870-2021-00455
• Device Sequence Number: 20012499
• Product Code: LIT
• UDI-Device Identifier: 00763000106041
• UDI-Public: 00763000106041
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/14/2021

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: 04/04/2024
• Device Model Number: A35HPV06100080
• Device Catalogue Number: A35HPV06100080
• Device Lot Number: B185950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 12/14/2021
• Date Device Manufactured: 04/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown