MAUDE Adverse Event Report: ABBOTT VASCULAR RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER; PEREIPHERAL DILATATION CATHETER

Model Number	1008193-20
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified, moderately tortuous common carotid artery that was 90% stenosed.After crossing the lesion with an unspecified wire and an unspecified embolic protection device, a 5x20mm viatrac plus balloon dilatation catheter (bdc) was positioned.The balloon was pressurized to nominal pressure, but the balloon did not open to full diameter as a leak was observed from the hub.The bdc was removed and replaced with a new 5x20mm viatrac balloon to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other complaints reported from this lot.Based on the information provided, a definitive cause for the reported inflation issue and leak could not be determined.It may be possible that the inflation device was not properly connected to the hub, or damage to the hub occurred resulting in the reported inflation problem and leak at the hub; however, without having the device to examine, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9, h3: corrected to not returning.

• Brand Name: RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
• Common Device Name: PEREIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11164589
• Report Number: 2024168-2021-00408
• Device Sequence Number: 19762309
• Product Code: LIT
• UDI-Device Identifier: 08717648056987
• UDI-Public: 08717648056987
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K072798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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: 06/30/2022
• Device Model Number: 1008193-20
• Device Catalogue Number: 1008193-20
• Device Lot Number: 0072262
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/02/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1