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

Model Number	1008197-20
Medical Device Problem Code	Leak/Splash (1354)
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 the 6x20 mm viatrac balloon dilatation catheter (bdc) was being prepped with flushing and negative pressure applied and there were bubbles in the device.This was attempted a couple times but the bubbles were still present.Therefore, the device was not used and there was no patient involvement.A new viatrac balloon was used to complete the procedure.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection and functional testing were performed on the returned device.The reported leak was not confirmed.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 reported information and the observations from the returned analysis, a definitive cause for the reported leak could not be determined.Possible factors that may contribute to a leak include, but are not limited to, damage during processing of the balloon material, damage to the sidearm/inflation lumen, insufficient prep, damage to the balloon or loose connections.In this case, a conclusive cause for the reported leak could not be determined since the complaint was not confirmed during return analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
Subsequent to the initially filed report it was stated that the stopcock was exchanged during prep and then the syringe but the bubbles persisted.The balloon was inflated and no leak but still bubbles were seen.No additional information was provided.

• 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: 21327166
• Report Number: 2024168-2025-01378
• Device Sequence Number: 12741268
• Product Code: LIT
• UDI-Device Identifier: 08717648057144
• UDI-Public: (01)08717648057144(17)260930(10)4102561
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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: 09/30/2026
• Device Model Number: 1008197-20
• Device Catalogue Number: 1008197-20
• Device Lot Number: 4102561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2024
• 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