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

Catalog Number 1012405-15

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Dates estimated. The asahi prowater referenced is being filed under a separate medwatch mfr number. The device was received. The investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a lesion in the mid left anterior descending artery. During advancement and removal of the 2. 5 x 15 mm trek balloon catheter, resistance was noted with the prowater guide wire. Multiple heparinized saline flushes were performed, but the resistance continued. The procedure was continued with the same devices and there was a good patient outcome. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.

Manufacturer Narrative

(b)(4). Evaluation summary: (b)(4). The device was returned for evaluation. The reported difficulties could not be confirmed. Based on visual, dimensional and functional analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design or labeling. The investigation was unable to determine a conclusive cause for the reported difficulties. 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 of the reported lot did not indicate a lot specific quality issue. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: 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: 5398777
• MDR Text Key: 37112505
• Report Number: 2024168-2016-00511
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 1012405-15
• Device Lot Number: 50311G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/12/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial