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

Catalog Number 1012453-08T

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Concomitant medical products: guide wire: sion blue; guide catheter: mach 1 6fr bl3. 5. The device was not returned for analysis. 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 incidents from this lot. Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device. The investigation determined the reported difficulties appear to be related to circumstances of the procedure. The nc (b)(4) balloon dilation catheter device is an abbott vascular manufactured device which is distributed in (b)(4). Although this device is not commercially available for sale in the us, it is similar to a device currently marketed for sale in the us.

Event Description

It was reported that the procedure was to treat a de novo and eccentric lesion located in the heavily calcified, moderately tortuous, 75% stenosed proximal left anterior descending artery. During attempted advancement of the 4. 0 x 8 mm nc (b)(4) balloon dilatation catheter, the balloon catheter became stuck with the guiding catheter and the balloon catheter shaft became kinked. Resistance was also felt during removal of the balloon catheter from the guiding catheter. Additionally, it was stated that the kink could have occurred prior to use; however, this was not confirmed. No adverse patient effects or clinically significant delay in the procedure were reported. No additional information was provided.

• Brand Name: NC TENKU 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: 6038291
• MDR Text Key: 57802862
• Report Number: 2024168-2016-07045
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/18/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 1012453-08T
• Device Lot Number: 60502G1
• 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: 10/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial