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

Device Problems Deflation Problem (1149); Failure to Fold (1255)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Date of event has been estimated. The device was not returned as it was reportedly discarded. The investigation determined the reported difficulties appear to be related to user preference during the procedure as the physician commented that the length of time during deflation and balloon refold post deflation. This is a personal preference/opinion of the physician and not a quality issue with respect to manufacture, design or labeling with the product. There is no indication of product deficiency or product quality issue with respect to design, manufacture or labeling. The additional devices are being filed under separate medwatch reports.

Event Description

It was reported as a general comment that the 3. 5mm, 4. 5mm and 5mm sized nc trek devices take longer to deflate compared to a competitor's device, i. E, the balloon folds back and remains bulky after inflation. The nc trek was noted as not ideal for bifurcation procedures. There were no issues noted during removal of the device. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.

Manufacturer Narrative

(b)(4).

• 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): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 8125432
• MDR Text Key: 129077164
• Report Number: 2024168-2018-09224
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K103110
• 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,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• 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: 12/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial