MAUDE Adverse Event Report: AV-TEMECULA-CT RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER

Catalog Number	1008189-30
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	10/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record identified one similar incident associated with this complaint.The investigation determined the labeling issue appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
Event or Problem Description
It was reported that the part number on the international label (chinese) of a 4x30mm rx viatrac plus peripheral dilatation catheter did not match the part number on the english label on the box.The dilation catheter was not used.There was no patient involvement.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Subsequent to the previously filed report, the following additional information was received: it was reported that the 4x30mm rx viatrac plus peripheral dilatation catheter was used successfully in a procedure to treat an 85% stenosed lesion in the internal carotid artery.It wasn't until after use that the label discrepancy was noted.The procedure was successfully completed with an unspecified acculink stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8011639
• Report Number: 2024168-2018-08223
• Device Sequence Number: 19177414
• Product Code: LIT
• UDI-Device Identifier: 08717648056833
• UDI-Public: 08717648056833
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2018

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: 07/31/2020
• Device Catalogue Number: 1008189-30
• Device Lot Number: 8081061
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 10/28/2018
• Supplement Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1