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

Catalog Number	1008189-20
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2018
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.The balloon rupture was likely the result of interaction with calcification or associated devices.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The investigation determined that the reported balloon rupture appear to be related to case circumstances.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The acculink device referenced in is being filed under separate medwatch report.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the internal carotid artery.On (b)(6) 2018, a 4x20x135mm viatrac plus balloon catheter was being used for pre-dilatation; however, the balloon ruptured during first inflation at 4 atmospheres.A 7-10x40mm acculink stent was implanted and the procedure was completed successfully with the patient being given plavix post-procedure.The patient had a seizure overnight and a computerized tomographic angiography confirmed thrombosis in the acculink stent.The patient is in stable condition and is going back to the cath lab on (b)(6) 2018 to have a covered stent implanted to treat the thrombosis.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).

• 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: 7265207
• Report Number: 2024168-2018-01024
• Device Sequence Number: 13951568
• Product Code: LIT
• UDI-Device Identifier: 08717648056826
• UDI-Public: 08717648056826
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2018

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: 11/30/2019
• Device Catalogue Number: 1008189-20
• Device Lot Number: 7121861
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 02/12/2018
• Supplement Report FDA Received Date: 04/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1