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

Catalog Number 1012445-12

Device Problems Detachment Of Device Component (1104); Kinked (1339); Difficult To Position (1467); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: dilatation catheter: emerge 2.5x15, guide catheter: xb 3.5 6 f guide.(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 a non-abbott dilatation catheter was in the left anterior descending (lad) coronary artery.An nc trek dilatation catheter attempted to advance to the marginal coronary artery for kissing balloon technique; however, during advancement, resistance was noted with the guide catheter and the device position in the anatomy.The nc trek became kinked.During removal, no resistance was felt; however, the shaft separated while in the guiding catheter.Reportedly, the nc trek catheter was possibly loaded into the guidewire at the beginning of the procedure with minor kinks.The guide catheter and dilatation device were removed as a single unit.There were no adverse patient effects and there was no clinically significant delay.There were no other issues noted.There was no additional information regarding this device issue.

Manufacturer Narrative

(b)(4).Evaluation summary: visual and dimensional inspections were performed on the returned device.The reported separation was confirmed.The reported kink was not confirmed; however, it is likely that the reported kink was located at the separated location noted during return analysis.The reported difficulty to position over the guide wire was not confirmed.The reported difficulty to position with the guiding catheter could not be replicated in a testing environment due to the condition of the returned device.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 similar incidents from this lot.The coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: do not use, or attempt to straighten a catheter if the shaft has become bent or kinked; this may result in the shaft breaking.The investigation determined the reported kink and difficulty positioning the device with the guiding catheter appear to be related to circumstances of the procedure; however, the shaft separation appears to be related to user error and there is no indication of a product quality issue with respects to the design, manufacture or labeling of the device.

• 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: 6478393
• MDR Text Key: 72570975
• Report Number: 2024168-2017-03004
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 1012445-12
• Device Lot Number: 61004G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• 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
• Patient Age: 63 YR
• Patient Weight: 54