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

Catalog Number	1008193-30
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); Weakness (2145)
Date of Event	11/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.The balloon rupture could not be confirmed.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 and subsequent patient effects appear to be related to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a calcified left internal to common carotid artery.An acculink stent was implanted.A 5 x 30 mm viatrac plus balloon catheter was advanced to the lesion without issue to perform post-dilatation when the balloon ruptured during the first inflation at 8 atmospheres.The patient started showing neurological deficiency on the right side with weakness in the arm and the leg.Thirty minutes later the symptoms went away.Angiogram was taken and the stent was fully expanded so the procedure was completed at this time.An mri was performed showing no sign of air embolization in the brain.The patient is doing well.No additional information was provided.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: 7088769
• Report Number: 2024168-2017-09459
• Device Sequence Number: 11156644
• Product Code: LIT
• UDI-Device Identifier: 08717648056994
• UDI-Public: 08717648056994
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 12/06/2017

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: 08/31/2018
• Device Catalogue Number: 1008193-30
• Device Lot Number: 7092761
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 12/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 60