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

Catalog Number	1008189-20
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/05/2016
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 received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The 5.0 x 20 mm x 135 cm viatrac plus referenced in b5 is being filed under a separate medwatch report.
Event or Problem Description
It was reported the procedure was to treat a lesion in the common carotid artery.During preparation of the 5.0 x 20 mm x 135 cm viatrac plus balloon catheter, when pulling negative during preparation, there was air coming into the syringe due to a hole that was noted on the shaft; therefore, the device was not used.The 4.0 x 20 mm x 135 cm viatrac plus balloon catheter was not able to hold negative pressure, there was air coming into the syringe; therefore, the device was not used.The 4.0 x 30 mm x 135 cm viatrac plus had some difficulty pulling negative, but was able to be prepped.The device was advanced to the target lesion, the balloon inflated and deflated successfully.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Evaluation summary: visual and functional inspections were performed on the returned device.The reported leak during preparation was not 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 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 determined the reported difficulties appear to be related to circumstances of the procedure.

• 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: 6074247
• Report Number: 2024168-2016-07513
• Device Sequence Number: 13853544
• Product Code: LIT
• UDI-Device Identifier: 08717648056826
• UDI-Public: (01)08717648056826(17)180630(10)6072061
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/11/2016

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: 06/30/2018
• Device Catalogue Number: 1008189-20
• Device Lot Number: 6072061
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2016
• Supplement Report FDA Received Date: 11/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1