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

Catalog Number	1008189-30
Medical Device Problem Codes	Failure to Advance (2524); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion in the internal carotid artery with 80% stenosis, moderate calcification and moderate tortuosity.The 4.0x30mm viatrac plus balloon dilatation catheter (bdc) was unable to pass through the lesion.When preparing to adjust the guide wire, it was found that there was a hole in the catheter at the tip of the balloon, and the guide wire passed through the hole of the tip of the balloon.Another same size viatrac balloon was used and completed the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
Visual and dimensional analysis was performed on the returned device.The reported tear/hole in the tip was confirmed.The reported failure to advance could not be replicated in a testing environment as it was based on operational circumstances.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no other similar complaints from this lot.The investigation determined the reported failure to advance and tear/hole in the tip appear to be related to operational context.There was no damage noted to the bdc during the inspection prior to use which suggests a product quality issue did not contribute to the reported difficulties.In this case, it is likely that the guide wire was inadvertently mishandled during initial advancement/placement such that it punctured through the tip of the device, resulting in the noted hole/tear and subsequently contributed to the reported failure to advance.Based on the reported information, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D4: lot # updated from 3092061 to 3062261.

• 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: 19243207
• Report Number: 2024168-2024-05465
• Device Sequence Number: 17884529
• Product Code: LIT
• UDI-Device Identifier: 08717648056833
• UDI-Public: (01)08717648056833(17)250531(10)3062261
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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: 05/31/2025
• Device Catalogue Number: 1008189-30
• Device Lot Number: 3062261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2023
• 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 Sex: Unknown