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

Catalog Number 1012449-20

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/03/2018

Event Type  malfunction  

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 additional relevant information.

Event Description

It was reported that during preparation and before use, the nc trek rx 3 x 20 mm shaft broke at the hub.The device was not used and replaced with another nc trek to complete the procedure.There was no resistance during removal of the protective sheath.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual inspection was performed on the returned device by abbott vascular (av).The reported separation 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.The investigation determined the reported separation appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Av will continue to trend the performance of these devices.

• 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: 7455380
• MDR Text Key: 106394085
• Report Number: 2024168-2018-03018
• Device Sequence Number: 1
• Product Code: LOX
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 1012449-20
• Device Lot Number: 80209G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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