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

Catalog Number 1012453-15

Device Problems Deflation Problem (1149); Kinked (1339); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Evaluation summary: visual,dimensional and functional inspections were performed on the returned device. The reported kink was confirmed. The reported deflation issue could not be tested due to the condition of the returned device. The reported difficulty positioning with the guiding catheter could not be replicated in a testing environment as it was based on circumstances of the procedure. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history identified no other incidents from this lot. The investigation determined the reported difficulties are related to circumstances of the procedure. There is no indication of a product quality issue with respect to manufacture, design or labeling.

Manufacturer Narrative

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

Event Description

It was reported that the procedure was to treat a de novo proximal left anterior descending artery. A 4. 0 x 15 mm nc trek balloon catheter was used for post-dilatation and was inflated one time to nominal pressure. A non-abbott nc balloon catheter was then used for post-dilatation and the same 4. 0 x 15 mm nc trek was being advanced for additional post-dilatation when there was resistance with the guiding catheter and the hypotube kinked when a small amount of force was applied. The device was removed from the anatomy and it was decided not to use it. A non-abbott balloon catheter was successfully used to complete the procedure. An attempt was made outside the anatomy to inflate and deflate the balloon. The balloon inflated without issue but would not deflate. There was no clinically significant delay in procedure and no adverse patient effects. 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: 6643472
• MDR Text Key: 130233644
• Report Number: 2024168-2017-05083
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 07/18/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 1012453-15
• Device Lot Number: 70227G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial