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

Catalog Number 1012446-12

Device Problems Difficult to Insert (1316); Material Separation (1562); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2019

Event Type  malfunction  

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 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
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; 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: 8289820
• MDR Text Key: 134501397
• Report Number: 2024168-2019-00688
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151699
• UDI-Public: 08717648151699
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2018
• 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
• Treatment: RHV: COPILOT
• Patient Age: 79 YR