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

Catalog Number 1012452-08

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4). The customer reported the device is retained by the hospital and not returning. Investigation is not yet complete. 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 lesion in the non-tortuous, moderately calcified, 90% stenosed proximal left anterior descending (lad) coronary artery. A 3. 75 x 8 mm nc trek rx balloon dilatation catheter (bdc) was selected for the procedure utilizing the kissing balloon method. There was no resistance felt while removing the protective mandrel/sheath removal, there were no issues noted during prep (air aspiration), but the balloon was not soaked in saline prior to use. The bdc was advanced with no resistance to the lesion and inflated to 12 atmospheres with no issues noted; however the balloon would not fully deflate even after several attempts. The balloon was re-inflated to 14 atmospheres, but would still only partially deflate. The guiding catheter and bdc were removed from the anatomy as a single unit. Upon removal for the anatomy the bdc was inspected and no tear, kink, or shaft separation were found. Another attempt was made to fully deflate the balloon which was unsuccessful. There was no reported clinically significant delay in the procedure. There was no reported adverse patient sequela. No additional information was provided.

Manufacturer Narrative

(b)(4). It was initially reported that the device would not be returning for analysis; however, the device was returned. Evaluation summary: the device returned for analysis. The complaint investigation determined the reported difficulty was related to manufacturing issues associated with the protective sheath. On (b)(6) 2017, abbott vascular decided to initiate a voluntary field action for some sizes and lots of the nc trek family of dilatation catheters for difficulty to remove sheath which may lead to inflation or deflation issues. Abbott vascular performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis. The root cause identification was complicated by the fact that users were describing multiple symptoms when reporting the complaints. To date, the frequency of worldwide reported events for difficulties removing the protective balloon sheath, inflation and deflation has reached an actionable limit, thus abbott vascular communicated the voluntary field action to the fda on (b)(6) 2017 [medwatch # 2024168-2017-02310]. Corrective action has been implemented per site operating procedures. The product will continue to be trended. The abbott internal recall number is (b)(4).

• 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: 6191944
• MDR Text Key: 63215884
• Report Number: 2024168-2016-09078
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: Recall
• Type of Report: Initial,Followup
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 1012452-08
• Device Lot Number: 60810G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/20/2016 Patient Sequence Number: 1

Treatment

GUIDE CATHETER: JL4