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

Catalog Number 1012451-15

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Date of event estimated. The device is expected to be returned for evaluation. It has not yet been received. A follow-up will be submitted with all relevant information.

Event Description

It was reported that the nc trek broke when loading over the guide wire. There was no part of the separation inside the patient anatomy. There was no retrieval of the separation necessary. Another device was used to complete the procedure. No additional information was provided.

Manufacturer Narrative

(b)(4). Date of event was confirmed to be (b)(6) 2018. Visual inspection was performed on the returned device. 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 difficulty appears to be related to operational context. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

Event Description

The following additional information was received: there was no adverse patient effect and no reported clinically significant delay in the procedure. 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: 7286833
• MDR Text Key: 100777091
• Report Number: 2024168-2018-01288
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 1012451-15
• Device Lot Number: 70826G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial