MAUDE Adverse Event Report: ABBOTT VASCULAR RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER; PEREIPHERAL DILATATION CATHETER

Model Number	1008194-40
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right internal carotid artery.The 5.0mm x 40mm x 80cm viatrac peripheral balloon dilatation catheter (bdc) was advanced to the target lesion without resistance.The balloon ruptured during the second inflation at 12 atmospheres.A stent was implanted to complete the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported balloon material rupture was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar complaints.The investigation determined that the reported difficulties were likely due to circumstances of the procedure.It is likely that the balloon rupture occurred due to interaction with lesion calcification or associated devices.The scratches noted near the rupture site indicate interaction to the outer surface material likely caused the balloon rupture.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
• Common Device Name: PEREIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12955331
• Report Number: 2024168-2021-11216
• Device Sequence Number: 4292407
• Product Code: LIT
• UDI-Device Identifier: 08717648057045
• UDI-Public: 08717648057045
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K072798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2022

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: 06/30/2023
• Device Model Number: 1008194-40
• Device Catalogue Number: 1008194-40
• Device Lot Number: 1072061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 130 KG