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

Catalog Number 1012449-08

Device Problems Nonstandard Device (1420); Difficult to Remove (1528)

Patient Problem No Patient Involvement (2645)

Event Date 03/25/2017

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 is expected to be returned for evaluation.It has not yet been received.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 the patient underwent a coronary stenting procedure to treat a target lesion in the mid left anterior descending artery.Pre-dilatation was performed and an unspecified stent was implanted.The 3.0 x 8 mm nc trek was prepared for use; however, the protective sheath could not be removed.The device was not used and a second 3.0 x 8 mm nc trek was used without issue.No additional information was provided.

Manufacturer Narrative

(b)(4).Internal file number - (b)(4).Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.The reported inflation issue could not be confirmed and no additional damage that could have contributed to the issue was noted on the returned device.The balloon was able to be inflated without issue.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents from this lot.The investigation determined the reported inflation issue appears to be related to operational context and there is no indication of a product quality issue with respects to the design, manufacture or labeling of this device.

Event Description

Subsequent to the initial 30-day medical device report, the following information was received: the sheath was removed without difficulty and the device was used; however, during inflation attempts, the balloon failed to inflate.There was no reported adverse patient sequela or a clinically significant delay in procedure.No additional information was provided.

• 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: 6552850
• MDR Text Key: 74793596
• Report Number: 2024168-2017-03998
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 1012449-08
• Device Lot Number: 60705G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• 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