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

Catalog Number 1012448-20

Device Problems Deflation Problem (1149); Difficult To Position (1467); Improper or Incorrect Procedure or Method (2017)

Patient Problem Angina (1710)

Event Date 06/07/2016

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).Incorrect prep; failure to submerge balloon to activate coating.Concomitant devices: guide wire: 0.014 balance middleweight universal.Stent: xience alpine.The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that during device preparation, the 2.75 x 20 mm nc trek was flushed, but not soaked.During the procedure, after pre-dilatation, a xience alpine stent was implanted in the mid-distal right coronary artery (rca).The nc trek was taken to the stented lesion and was inflated to 12 atmosphere (atm), but could not be visualized under fluoroscopy.The indeflator pressure was decreased and the balloon could be visualized.The pressure was again increased to 12 atm.The balloon could not be deflated.Attempts were unsuccessful to deflate the balloon and after 7 minutes of trying to deflate, the balloon was removed from the anatomy, through the guide catheter, while still inflated.The patient experienced chest pain which resolved during the procedure without intervention.The procedure was completed using a non-abbott balloon.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.The returned balloon was pressurized and deflation times met specifications; thus, the reported deflation difficulty was not confirmed.Additionally, the balloon markers were visible under fluoroscopy prior to inflation, while inflated and after deflation when inflated with contrast; thus, the visibility issue was not confirmed.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 identified no other similar incidents from this lot.The nc trek rx, global, instruction for use (ifu) states: submerge the balloon in sterile heparinized normal saline during balloon preparation, to activate the coating.The reported patient effect of angina as listed in the ifu is a known patient effect that may be associated with use of a coronary catheter in native coronary arteries.The investigation was unable to determine a conclusive cause for the reported deflation and visibility issues.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

Manufacturer Narrative

(b)(4).On march 14, 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 [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 2024168-3/14/2017-002-r.

• 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: 5763888
• MDR Text Key: 48616079
• Report Number: 2024168-2016-04326
• 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: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 1012448-20
• Device Lot Number: 60310G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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 Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 71