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

Model Number	1008193-30
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
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 procedure was to treat a lesion in the internal carotid artery with moderate calcification, moderate tortuosity and 90% stenosis.The 5.0x30mm viatrac plus balloon peripheral dilatation catheter was prepped per instructions for use.The balloon was advanced without resistance and inflated once to 10 atmospheres when a rupture occurred.A same size device was used to continue the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported balloon rupture 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 no other similar complaints from this lot.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported balloon rupture appears to be related to circumstances of the procedure.In this case, it is likely that the balloon interacted with the moderately calcified anatomy such that the balloon became damaged and subsequently ruptured during inflation.Based on the results of the complaint investigation 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 reports: the inner member separated 4mm proximal to the distal tip outside the anatomy.Additional information confirmed that this occurred outside the anatomy, when washing the device after use.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: 20102222
• Report Number: 2024168-2024-10275
• Device Sequence Number: 20768075
• Product Code: LIT
• UDI-Device Identifier: 08717648056994
• UDI-Public: (01)08717648056994(17)250930(10)3102362
• 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): 10/18/2024

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: 09/30/2025
• Device Model Number: 1008193-30
• Device Catalogue Number: 1008193-30
• Device Lot Number: 3102362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2023
• 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