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

Catalog Number 1012448-12

Device Problems Detachment Of Device Component (1104); Kinked (1339); Difficult To Position (1467); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: (b)(4).The device was returned for evaluation.The reported kink and shaft separation was confirmed.The reported failure to advance could not be replicated in a testing environment as it was based on operational circumstances.Based on visual and dimensional analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design or labeling.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.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 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.

Event Description

It was reported that the procedure was to treat a lesion located in the mid-left anterior descending (lad) coronary artery (rca) that was narrow with heavy calcification and 90% stenosed.The rx nc trek 2.75 x 12 mm balloon dilatation catheter did not cross the narrow and heavily calcified lesion.It is not known if the failure to cross was due to the patient anatomy or an interaction of devices.After the nc trek was removed, it was noticed that the shaft was bent.The patient was treated with another nc trek bdc.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.Returned device analysis revealed a hypotube separation.Follow-up with the account has confirmed this to have occurred during use in the patient.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: 5489250
• MDR Text Key: 40149243
• Report Number: 2024168-2016-01428
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 1012448-12
• Device Lot Number: 50409G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2016
• Initial Date FDA Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1