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

Catalog Number 1012451-15

Device Problems Detachment Of Device Component (1104); Kinked (1339); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Internal file number (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for evaluation.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 similar incidents from this lot.It should be noted that the nc trek rx, instructions for use states: do not use, or attempt to straighten, a catheter if the shaft has become bent or kinked; this may result in the shaft breaking.In this case, it is likely that the attempt to advance the bent bdc into the anatomy contributed to the shaft separating as further handling/manipulation was encountered at the bent location.The investigation determined the reported bend appears to be related to circumstances of the procedure; however, the shaft separation appears to be related to user error.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

Event Description

It was reported that when the protective sheath was removed from the 3.5x15 nc trek balloon dilatation catheter (bdc), the shaft was noted to be slightly bent.When an attempt was made to insert the bdc into the introducer sheath, the proximal shaft separated at the bend.There was no clinically significant delay in the procedure and no adverse patient effects.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: 6880857
• MDR Text Key: 87243206
• Report Number: 2024168-2017-07632
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151989
• UDI-Public: 08717648151989
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 1012451-15
• Device Lot Number: 70307G2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• 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