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

Catalog Number 1012455-15

Device Problems Difficult To Position (1467); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2014

Event Type  malfunction  

Event Description

It was reported that using an unspecified artery access approach during a procedure of the proximal renal artery the 5.0 x 15 mm nc trek balloon dilatation catheter (bdc) was advanced but met resistance with the non-abbott guide wire during the attempt to cross the lesion.It was noted that after balloon inflation and deflation the bdc was not able to be retracted into the unspecified guide catheter and met resistance as the balloon had winged.The nc trek was eventually removed from the anatomy with the guide catheter and guide wire without reported issue.The patient was treated with a second nc trek bdc without issue.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for evaluation.The reported winged folds and difficulty to remove were confirmed.The reported difficulty to insert could not be replicated due to the condition of the returned device.Based on analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances for the reported lot.A query of the complaint handling database revealed no other similar incidents reported from this lot.It should be noted that the non-compliant (nc) trek instructions for use (ifu) states that the nc trek rx coronary dilatation catheter is indicated for, balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion, balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction and balloon dilatation of a stent after implantation (balloon models 2.00 mm x 5.00 mm only).Based on the information reviewed, there is no evidence to indicate the presence of a product deficiency.

• 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 462
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3806304
• MDR Text Key: 4522514
• Report Number: 2024168-2014-03022
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/18/2014

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: 09/30/2014
• Device Catalogue Number: 1012455-15
• Device Lot Number: 110286X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2014
• Initial Date FDA Received: 05/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2011
• 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
• Treatment: GUIDE WIRE: MEDTRONIC