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

Model Number	1008189-40
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a 85% stenosed de novo lesion in the renal artery with moderate calcification.The 4x40mm viatrac balloon dilatation catheter (bdc) was advanced to the target lesion and the balloon was attempted to be inflated twice to 8 atmospheres (atm); however, the balloon failed to inflate.Therefore, the bdc was removed from the patient and an additional attempt was made to inflate the balloon in a basin of water and bubbles were noted coming from the tip of the balloon.Another viatrac balloon was used to continue the procedure.There was no adverse patient effect and no clinically significant delay reported 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.
Event or Problem Description
Subsequent to the initial report being filed, it was reported that the bdc was not prepped (air aspiration) outside the anatomy prior to use.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection and functional testing were performed on the returned device.The reported balloon rupture and inflation issue were 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 complaints could not be determined.In this case, it is unknown if the reported violation of the instructions for use (ifu) caused or contributed to the complaint; possible factors that could contribute to balloon material ruptures include, but are not limited to, insufficient preparation, inflation technique, interactions with other devices or patient anatomy.In this case, it is likely that the balloon rupture resulted in the reported inflation issue, as the balloon would not hold pressure; however, a conclusive cause for the reported balloon rupture could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 23302207
• Report Number: 2024168-2025-11123
• Device Sequence Number: 18623447
• Product Code: LIT
• UDI-Device Identifier: 08717648056840
• UDI-Public: (01)08717648056840(17)261231(10)5012761
• 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): 11/17/2025

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 Model Number: 1008189-40
• Device Catalogue Number: 1008189-40
• Device Lot Number: 5012761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• 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