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

Catalog Number 1012448-08

Device Problems Kinked (1339); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2017

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.

Event Description

It was reported the procedure was performed to treat a lesion located in the proximal left anterior descending artery.Dilatation was to be performed with the 2.75 x 8 mm nc trek.There was no resistance felt during advancement of the balloon catheter to the lesion.When an attempt was made to inflate the balloon to 20 atmospheres, it was found that the shaft was bent/kinked and had a hole visible evidenced by a leak.Another nc trek of the same size was used to successfully complete the procedure.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Internal file number - (b)(4).Device code 2017: above rated burst pressure evaluation summary: visual and functional inspections were performed on the returned device.The reported kink and leak were 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 incidents from this lot.It should be noted coronary dilatation catheters, nc trek rx, instruction for use (ifu) states: balloon pressure should not exceed the rated burst pressure (rbp).In this case, it is unlikely the ifu violation contributed to the reported event.The investigation determined the reported issues appear to be related to operational context as the device was likely damaged during advancement resulting in the reported kink and inflation issue.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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: 7217238
• MDR Text Key: 98352482
• Report Number: 2024168-2018-00573
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 1012448-08
• Device Lot Number: 70412G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2017
• 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