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

Model Number	1008194-20
Medical Device Problem Codes	Difficult to Insert (1316); Leak/Splash (1354); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation, the physician was unable to thread a guide wire through a 5x20 mm viatrac 14 plus balloon dilation catheter, causing the tip to become bent.There was no patient involvement.A user facility medwatch report was received that states: tip drainage.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.Based on the information provided, a definitive cause for the reported complaints could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Attachment: medwatch report.

• 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: 24676911
• Report Number: 2024168-2026-01208
• Device Sequence Number: 16006162
• Product Code: LIT
• UDI-Device Identifier: 08717648057021
• UDI-Public: (01)08717648057021(17)261231(10)5013161
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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 Model Number: 1008194-20
• Device Catalogue Number: 1008194-20
• Device Lot Number: 5013161
• 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: 03/12/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2025
• 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