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

Catalog Number 1012449-15

Device Problems Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2017

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 not returned for evaluation. The investigation was unable to determine a conclusive cause for the reported difficulties. An image from the procedure was received and reviewed by an abbott clinical specialist. The reviewer concluded that from the image provided, it is not able to be determined that the elite guide wire was separated. The proximal portion of the wire is not radiopaque and thus the wire labeled elite could be intact. No images were provided showing the original location or movement with removal of the resolute integrity or nc trek. 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 reported from this lot. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device. The hi-torque bmw referenced is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat a lesion located in the proximal circumflex artery. A buddy wire technique was utilized with the hi-torque balance middleweight (bmw) elite guide wire and a non-abbott guide wire in the lower circumflex and a non-abbott stent was deployed. After deployment of the non-abbott stent, during advancement of the bmw guide wire, it met resistance with the nc trek 3. 0 x 15 mm balloon dilatation catheter that was being used for post-dilatation and separated in two pieces. When the nc trek 3. 0 x 15 mm bdc was being pulled out, resistance was felt again; however, the guide wire and separated components were pulled out together at the same time with no separated guide wire left in the vessel. There was no reported adverse patient effect. There was no reported clinically significant delay in the 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: 6549066
• MDR Text Key: 74667315
• Report Number: 2024168-2017-03970
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 1012449-15
• Device Lot Number: 70106G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/05/2017 Patient Sequence Number: 1

Treatment

GUIDE WIRE: HI-TORQUE BALANCE MIDDLEWEIGHT ELITE