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

Catalog Number 1012453-08

Device Problems Detachment Of Device Component (1104); Kinked (1339)

Patient Problem No Patient Involvement (2645)

Event Date 01/23/2018

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 returned for analysis and abbott vascular (av) identified a separation at the hub.Av reviewed the lot history record and there were no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A review of the complaint history identified no other incidents reported from this lot.Av conducted root cause analysis and determined the issue may 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.

Event Description

It was reported that before use, the hub and proximal shaft of a 4.0 x 8 mm nc trek balloon dilatation catheter (bdc) were noted to be kinked.Therefore, the bdc was replaced with another unspecified device to successfully complete the procedure.There was no patient involvement.There was no clinically significant delay in the procedure and no adverse patient effects.Returned device analysis revealed that the hypotube separated from the device.No additional information was provided.

• 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: 7336160
• MDR Text Key: 102344994
• Report Number: 2024168-2018-01786
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152054
• UDI-Public: 08717648152054
• 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
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 1012453-08
• Device Lot Number: 70524G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• 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