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

Catalog Number 1012453-12

Device Problems Failure to Fold (1255); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2018

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 was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a moderately calcified lesion in the mildly tortuous proximal left anterior descending coronary artery. A 4. 0x12 mm nc trek balloon dilatation catheter (bdc) was advanced without resistance for post-dilatation of an unspecified stent. After post-dilatation the bdc was being pulled back and became stuck with the guide catheter. The bdc was re-inflated and deflated again to attempt removal and the physician had to pull firmly to successfully remove the bdc. Upon inspection after removal, the distal end of the balloon looked thick and the balloon material did not look refolded properly. A new, same size nc trek was used to complete the procedure. There were no adverse patient effects and there was no reported clinically significant delay in the procedure. No additional information was provided.

Manufacturer Narrative

(b)(4). A visual inspection was performed on the returned device. The reported winged/wrinkled balloon was confirmed. The reported difficulty to remove from a guiding catheter could not be confirmed due to the condition of the balloon. 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 similar incidents reported from this lot. It should be noted that coronary dilatation catheter, nc trek rx, instructions for use states: if resistance is felt, determine the cause 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. The investigation determined the reported/noted difficulties of difficult to remove, winged/wrinkled balloon, kinks and bends on the device appear to be related to circumstances of the procedure. In this case, based on the returned analysis it is likely that the balloon was not fully deflated during retraction causing resistance with the distal end of the guiding catheter resulting in the unusual appearance and/or the winged/wrinkled distal end of the balloon. There is no indication of a product quality issue with respect to 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: 8227835
• MDR Text Key: 132504539
• Report Number: 2024168-2019-00197
• Device Sequence Number: 1
• Product Code: LOX
• 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

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 1012453-12
• Device Lot Number: 80110G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/21/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial