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

Catalog Number 1008189-20

Device Problem Material Rupture (1546)

Patient Problems Transient Ischemic Attack (2109); Vasoconstriction (2126)

Event Date 06/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported the procedure was to treat a de novo lesion with no tortuosity, moderate calcification with 85% stenosis in the internal carotid artery.The viatrac balloon catheter was being used for post-dilation of an unspecified stent.During the procedure, the patient experienced vessel spasm and was given nitroglycerin.During first inflation of the viatrac balloon between 10- 12 atmospheres, the balloon ruptured and the patient experienced a transient ischemic attack (tia).A ct scan was performed immediately after which revealed no significant findings.The tia resolved 1.5 hours post procedure and the patient was discharged home 2 days after procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual and scanning electron microscopy analysis was performed on the returned device.The reported balloon rupture was confirmed.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 incidents from this lot.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 investigation was unable to determine a conclusive cause for the balloon rupture and subsequent patient effects.

• Brand Name: RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5759766
• MDR Text Key: 48476245
• Report Number: 2024168-2016-04267
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 1008189-20
• Device Lot Number: 5072961
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 84