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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.
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Manufacturer (Section D)
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
MDR Report Key5763888
MDR Text Key48616079
Report Number2024168-2016-04326
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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 Received06/30/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Catalogue Number1012448-20
Device Lot Number60310G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/14/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2016
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: 06/30/2016 Patient Sequence Number: 1