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

Catalog Number 1012453-15

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Stretched (1601); Mushroomed (2987)

Patient Problem Ischemia (1942)

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The rx trek device referenced is being filed under a separate medwatch report. Evaluation summary: visual, dimensional and functional inspections were performed on the returned device. The reported deflation difficulty was unable to be confirmed. The reported separation and stretching was confirmed. The reported material twist (accordion) could not be confirmed; however, it is likely that the account perceived the noted balloon folded towards itself at the distal end as the reported material twisted (accordion). The reported difficulty removing the device from the anatomy could not be replicated in a testing environment as it was based on operational circumstances. 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 similar incidents from this lot. The investigation was unable to determine a conclusive cause for the reported deflation issue since the complaint could not be confirmed during return analysis. The investigation determined the reported difficulty removing the device from the anatomy, the stretching, material twist and patient effect of ischemia appear to be related to circumstances of the procedure. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

Event Description

It was reported the procedure was to treat a heavily calcified lesion in the ostium of the left anterior descending (lad) artery. Atherectomy was performed to prep the lesion. The 3. 0x20mm rx trek balloon catheter was advanced and the balloon was inflated however would not deflate. Negative was pulled for 3-4 minutes with a syringe and the balloon deflated enough to be removed from the patient with no resistance. A stent was placed in the left main (lm) and post dilated with a 4. 0x15mm nc trek balloon catheter. The balloon was inflated to 10atm however failed to deflate and the patient became symptomatic (ischemic). The inflated balloon was removed to the guide with resistance noted with the anatomy. Everything was removed as a whole system. The procedure was completed with another nc trek balloon. There was no clinically significant delay in the procedure and no adverse patient sequela. No additional information was provided. Post procedure, the abbott vascular sales rep looked at the nc trek device and noted the shaft was stretched proximal to the proximal balloon seal and the shaft was accordion looking. Also, he reviewed the cines and noted the physician did not wait until the balloon was deflated prior to removal.

• 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: 7623483
• MDR Text Key: 112001667
• Report Number: 2024168-2018-04741
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/17/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 1012453-15
• Device Lot Number: 80419G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/07/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial