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

Catalog Number 1012453-12

Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

Patient Problem Ventricular Tachycardia (2132)

Event Date 11/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a mildly calcified right coronary artery.A 4.0 x 12 mm nc trek balloon catheter was used and did not meet any resistance during advancement.However, after the balloon was deflated, it met resistance with a guiding catheter during removal.Force was used and the device separated at the guide wire exit notch.Therefore, the proximal part of the device was simply withdrawn and the distal part was removed with a snare device.The patient experienced tachycardia before the device separation, which resolved on its own.There was a clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported detachment was able to be confirmed.The reported difficult to remove was unable to be replicated in a testing environment as it was based on operational circumstances.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 incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.Force applied resulted in the noted tip detachment.It should be noted that the nc trek rx, global instructions for use states: do not advance or retract the catheter unless the balloon is fully deflated under vacuum.If resistance is met during manipulation, determine the cause of the resistance before proceeding.Failure to follow these steps and/ or applying excessive force to the delivery system can potentially result in loss or damage to the stent and/ or delivery system components.Although it was noted that resistance was noted during retraction of the device, this was due to resistance with a guiding catheter therefore the force applied during removal of the device seemed to be a reasonable clinical response to the difficulties.The tearing of the guide wire exit notch appears to have resulted from an interaction with the guide wire.Additionally, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial report, additional information was received.Returned device analysis revealed that a 2.0 x 15 mm mini trek balloon catheter was returned.It was reported that the device was used to remove the separated portion of the nc trek balloon catheter.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: 8144236
• MDR Text Key: 129745728
• Report Number: 2024168-2018-09471
• 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: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 1012453-12
• Device Lot Number: 80928G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 29