MAUDE Adverse Event Report: ABBOTT VASCULAR INC. VIATRAC; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	1008189-30
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that during preparation when the 4.0x30mm viatrac 14 plus peripheral dilatation catheter was removed from the dispenser hoop, the hub was observed to be separated into two pieces.An unspecified 5.0x30mm abbott balloon was used to complete the procedure.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the filed initial report, it was noted that the procedure was to treat a moderately tortuous, internal carotid artery that is 80% stenosed.During removal the 4.0x30mm viatrac 14 plus peripheral dilatation catheter hub was noted to be separated into two pieces; however, was simply withdrawn.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported separation was confirmed.Production record and corrective and preventative 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 there is no indication of a lot specific issue.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported separation could not be determined.Return device analysis noted contrast and blood on the device, which indicates that the device was prepped for use and advanced in the anatomy.In this case, it is possible that the device was inadvertently mishandled during preparation and/or advancement such that the shaft and strain relief became damaged (kinked) and upon further manipulation during removal, the hub separated; however, a conclusive cause cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6- health effect - impact code updated from 4656 to 2199.

• Brand Name: VIATRAC
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 21358141
• Report Number: 2024168-2025-01522
• Device Sequence Number: 8590186
• Product Code: LIT
• UDI-Device Identifier: 08717648056833
• UDI-Public: (01)08717648056833(17)260331(10)4042461
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K221057
• 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): 03/07/2025

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: 03/31/2026
• Device Model Number: 1008189-30
• Device Catalogue Number: 1008189-30
• Device Lot Number: 4042461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• 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