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

Catalog Number 1012451-25

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problem Angina (1710)

Event Date 02/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 the procedure was to treat a lesion located in the proximal to mid left anterior descending (lad) coronary artery that was non-tortuous and non-calcified.The nc trek rx 3.50 x 25 mm balloon dilatation catheter was being used for post-dilatation of two non-abbott stents.There was resistance when removing the protective sheath but the device was used.The device was prepped (air aspiration) outside the anatomy prior to use.The contrast ration to saline was 60/40.The nc trek rx was inflated once to 16 atmospheres during post dilatation however the device completely failed to deflate.After one minute of negative held with the inflation device, contrast was still present in the balloon when patient began to complain of chest pain.Inflation device and stopcock removed and a 20 cc syringe was connected directly to the nc trek device.After 2 minutes of aspiration, the balloon was still inflated so the physician deep seated the non-abbott guide catheter up against the balloon and gently pulled inflated balloon into the 6 fr guide catheter.The guide catheter, balloon and wire were removed as a single unit.The patient's pain resolved when the balloon was removed from the anatomy and no further treatment was given to the proximal lad.There was no clinically significant delay.No additional information was provided.

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 [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: 6395993
• MDR Text Key: 69900129
• Report Number: 2024168-2017-02007
• 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
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 1012451-25
• Device Lot Number: 60809G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/21/2017
• Is the Reporter a Health Professional?: Yes
• 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 Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR