MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK CORONARY DILATATION CATHETER

Model Number 1012455-08

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the procedure was performed to treat a lesion in the left main coronary artery.An unspecified stent was implanted without issue.The 5.0 x 8 mm nc trek dilatation catheter was advanced and inflated for post dilatation.No issues were noted during inflation and on angiography, it appeared that the balloon fully deflated.An attempt was made to remove the dilatation catheter; however, it appeared that the balloon was stuck on the stent.The physician pulled on the dilatation catheter, and a separation occurred, at a location inside the patient anatomy.The portion remaining outside the anatomy was removed.A second dilatation catheter was advanced and inflated, trapping the separated portion of the dilatation catheter and pulling it into the guide catheter.All devices were removed without issue.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual and functional inspections were performed on the returned device.The reported separation was confirmed.The reported difficulty removing the device could not 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 similar incidents and/or complaints from this lot.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: if resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.It is likely that the violation of the ifu contributed to the reported shaft separation the investigation determined the reported difficulty removing the device, removal of foreign body and additional treatment appear to be related to circumstances of the procedure.The reported separation appears to be related to user error/operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9876086
• MDR Text Key: 187867609
• Report Number: 2024168-2020-02845
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152139
• UDI-Public: 08717648152139
• Combination Product (y/n): N
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 1012455-08
• Device Catalogue Number: 1012455-08
• Device Lot Number: 00115G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention