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

Catalog Number 1012451-12

Device Problem Inflation Problem (1310)

Patient Problems Air Embolism (1697); Atrial Tachycardia (1731); Non specific EKG/ECG Changes (1817)

Event Date 03/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant products: guide wire: ffr, guide catheter: ebu.The device is expected to be returned for evaluation.It has not yet been received.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 located in the right coronary artery (rca) that was below bifurcation, moderately tortuous, mildly calcified and 70% stenosed.The nc trek 3.5 x 12 mm balloon was difficult to inflate and the inflation was very slow; the balloon only inflated to 10 atmospheres.After deflation, the physician noticed big bubbles that could be seen in angiography and the patient began to experience st elevation and tachycardia.A different indeflator was used to re-inflate the balloon to get rid of the air bubbles in the rca.This was resolved without any further patient impact.The patient's tachycardia and st elevation resolved on its own.There was no 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).Evaluation summary: the device returned for analysis.The complaint investigation determined the reported difficulty was related to manufacturing issues associated with the protective sheath.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 march 17, 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 2024168-3/14/2017-002-r.

Event Description

Subsequent to the previously filed medwatch report on 3/28/2017, case description has been revised to read: the indeflator and complaint balloon were changed and re-inflated in the vessel to cut the bubbles (air embolism) in the rca.

• 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: 6439635
• MDR Text Key: 71033426
• Report Number: 2024168-2017-02582
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• 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: 1012451-12
• Device Lot Number: 61003G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2017
• 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
• Removal/Correction Number: Z-2037-2039-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention