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

Model Number	1008193-20
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is returning for analysis.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
The procedure was to treat the right popliteal bypass graft which was occluded.A 5.0x20mm viatrac plus peripheral dilatation catheter was attempted to be used; however, ruptured at first inflation at 4 atmospheres.The marker/strip became separated and was retrieved by a small cutdown.Patient is doing well.A clinically significant delay was noted due to the retrieval of the separated portion.No additional information was provided.
Event or Problem Description
It was reported that the procedure was to treat the right popliteal bypass graft which was occluded.A 5.0x20mm viatrac plus peripheral dilatation catheter was attempted to be used; however, ruptured at first inflation at 4 atmospheres.The marker/strip became separated and was retrieved by a small cutdown.Patient is doing well.A clinically significant delay was noted due to the retrieval of the separated portion.Additional information: during removal resistance was met when pulling the device back over the unspecified guide wire.No additional information was provided.
Additional Manufacturer Narrative
The product was not returned to abbott vascular 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.Based on the review of similar incident(s) there is no indication of a lot specific product quality issue.The device was prepped prior to use without any leaks or ruptures noted, which would suggest that the device was not damaged prior to use.The investigation determined the reported balloon rupture, difficulty to remove and separation appear to be related to operational circumstances of the procedure.In this case, it is likely that during advancement the balloon became compromised against the anatomy and/or other devise used resulting in the reported balloon rupture during the first inflation at 4 atmospheres.Handling of the device post balloon rupture likely reduces the clearance of the wire lumen and the difficulty to remove the guide wire.Manipulation against resistance ultimately resulted in the reported separation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Attachment: user facility medwatchreport number mw5099757.B5: additional information d9: device available for evaluation was updated from "yes" to "no".H3: reason device not evaluated by mfg was updated to na.H6: code 1528 difficult to remove was added due to additional information in b5.

• 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: 11631688
• Report Number: 2024168-2021-02879
• Device Sequence Number: 16983243
• Product Code: LIT
• UDI-Device Identifier: 08717648056987
• UDI-Public: 08717648056987
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 1008193-20
• Device Catalogue Number: 1008193-20
• Device Lot Number: 0080362
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Weight: 109