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

Catalog Number	1012446-12
Medical Device Problem Codes	Difficult to Insert (1316); Material Separation (1562); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2019
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 additional nc trek device referenced is being filed under a separate medwatch report.Evaluation summary: visual and functional inspections were performed.The reported shaft kink and separation were confirmed.The reported difficult to insert the device through an rhv was unable to be confirmed as the device advanced through a proxy rhv without any resistance noted.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 reported from this lot.The investigation determined the reported difficulties to insert, shaft kinks and separation appear to be related to circumstances of the procedure.It is likely that during advancement of the balloon catheter through the rhv, the rhv was not fully opened causing resistance between the device and rhv.Additionally, manipulation and/or inadvertent mishandling of the device during advancement caused the hypotube to kink, ultimately resulting in the separating.The hypotube fractured faces at the separation were ovalled as if kinked prior to separation.There is no indication of a product quality issue with respect to design, manufacture or labeling.
Event or Problem Description
It was reported that resistance was met inserting a 2.25 x 12 mm nc trek rx balloon dilatation catheter (bdc) through a copilot bleed back control valve.The shaft of the bdc kinked and separated.As the separation occurred at a point outside of the anatomy, the distal part of the bdc was simply manually removed.A new 2.25 x 12 mm nc trek rx bdc was advanced; however, the same problem occurred.The procedure was successfully completed with an unspecified bdc and the same copilot.There were no adverse patient effects and no clinically significant delay in the procedure.

• 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: 8289820
• Report Number: 2024168-2019-00688
• Device Sequence Number: 14088460
• Product Code: LOX
• UDI-Device Identifier: 08717648151699
• UDI-Public: 08717648151699
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2019

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: 08/31/2021
• Device Catalogue Number: 1012446-12
• Device Lot Number: 80903G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RHV: COPILOT
• Patient Age: 79 YR