MAUDE Adverse Event Report: AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER

Catalog Number	1012446-12
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Failure to flush prior to attempted removal of protective sheath.The device was not returned for evaluation.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 similar incidents from this lot.The coronary dilatation catheters (cdc), nc trek rx, global, instruction for use states: flush the nc trek rx coronary dilatation catheter prior to protective sheath removal.The investigation determined the reported difficulty removing the protective sheath appears to be related to operational context and there is no indication of a product quality issue with respects to the design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the 2.25x12 mm nc trek dilatation catheter was not flushed prior to use and the protective sheath was unable to be removed.The device was not used.A non-abbott balloon dilatation catheter was used to complete the procedure.No additional information was provided.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6558511
• Report Number: 2024168-2017-04041
• Device Sequence Number: 13471390
• Product Code: LOX
• UDI-Device Identifier: 08717648151699
• UDI-Public: (01)08717648151699(17)190831(10)60905G1
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110134
• 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): 05/10/2017

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: 08/31/2019
• Device Catalogue Number: 1012446-12
• Device Lot Number: 60905G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2017
• Initial Report FDA Received Date: 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1