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

Catalog Number 1012270-12

Device Problems Detachment Of Device Component (1104); Kinked (1339); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(4). 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 heavily tortuous left anterior descending artery. A 2. 0 x 12 mm mini trek balloon catheter was being advanced when there was strong resistance due to the tortuosity in the anatomy and the shaft kinked. The physician straightened the kinked shaft, but the catheter was pushed harder and the shaft separated proximal to the kinked area. The device was easily removed and another balloon catheter was successfully used to complete the procedure. There was no clinically significant delay in procedure and no adverse patient effects. No additional information was provided.

Manufacturer Narrative

(b)(4). Failure to follow steps/instructions. The device was not returned for analysis. 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 did not indicate a lot specific quality issue. It should be noted that the trek rx / mini trek rx coronary dilatation catheter (cdc), global instructions for use (ifu, warnings section) specifies: if resistance is felt, determine the cause of the resistance before proceeding. Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and/or damage / separation of the catheter. Additionally, it should be noted that the trek rx / mini trek rx coronary dilatation catheter (cdc), global ifu specifies: do not use, or attempt to straighten, a catheter if the shaft has become bent or kinked; this may result in the shaft breaking. Instead, prepare a new catheter. The investigation determined the reported failure to advance appears to be related to circumstances of the procedure; however, the reported kink and shaft separation appears to be related to the use errors. There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• Brand Name: MINI 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: 6393691
• MDR Text Key: 69817142
• Report Number: 2024168-2017-01981
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 1012270-12
• Device Lot Number: 61111G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial