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

Catalog Number 1012450-12

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4). The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.

Event Description

Reportedly, resistance was felt with the copilot rotating hemostatic valve while advancing a 3. 25x12mm nc trek balloon dilatation catheter and the proximal shaft separated. The procedure was successfully completed with the same copilot and another unknown catheter. There was no clinically significant delay in the procedure and no adverse patient effects. No additional information was provided.

Manufacturer Narrative

(b)(4). Evaluation summary: visual, dimensional and functional inspections were performed on the returned device. The reported separation was confirmed; however, the reported difficulty positioning the device with the rotating hemostatic valve was not. 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. The investigation determined the reported shaft separation appears to be related to circumstances of the procedure; however, a conclusive cause for the reported difficulty positioning the device could not be determined. 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: 6611588
• MDR Text Key: 76832080
• Report Number: 2024168-2017-04775
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 1012450-12
• Device Lot Number: 61226G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/01/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial