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

Catalog Number 1012453-12

Device Problems Deflation Problem (1149); Nonstandard Device (1420); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).Concomitant medical products: guide wire: balance middleweight universal inflation: indeflator.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.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, [medwatch #2024168-2017-02310].

Event Description

It was reported that during the procedure to treat a mildly calcified, 80% stenosed, de novo lesion in the non-tortuous mid left anterior descending (lad) coronary artery, a balance middleweight (bmw) guide wire was advanced.A 4.0x12mm nc trek rx balloon dilatation catheter (bdc) was unpackaged and the protective sheath was removed without difficulty (but was not flushed before protective sheath removal and air aspiration was not performed outside of the anatomy prior to use).The nc trek rx bdc was prepped with 40/60 saline to contrast ratio, then was advanced over the bmw without resistance.The bdc was inflated to 12 atmospheres (atm) for 3 seconds without difficulty, was completely deflated without issue, the inflated again to 16 atm for 3 seconds without difficulty.The balloon was then unable to be deflated at all with negative pressure held for 10 seconds.The indeflator inflation device was swapped out for another with no deflation success.The nc trek rx bdc was pulled back into the aorta in its inflated state, with force applied, then an attempt was made to puncture the balloon with the proximal end of a new bmw guide wire; but the balloon was unable to be punctured.While still in the aorta, just outside of the guiding catheter, the balloon was then inflated to 22 atm, intentionally rupturing the balloon, then the nc trek rx bdc was withdrawn into the guiding catheter and all devices were removed from the anatomy as a single unit.Another unspecified balloon was used to successfully complete dilatation.Post-procedure stenosis was 20%.There were no adverse patient sequelae and no occurrence of a clinically significant delay.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.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.[medwatch # 2024168-2017-02310].

Manufacturer Narrative

(b)(4).The device returned for analysis.The complaint investigation determined the reported difficulty was confirmed and the issue was determined to be related to manufacturing issues associated with the protective sheath.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: 6435742
• MDR Text Key: 70893314
• Report Number: 2024168-2017-02528
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 1012453-12
• Device Lot Number: 61012G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2017
• Initial Date FDA Received: 03/27/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/03/2017; 05/03/2017
• 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 Outcome(s): Required Intervention