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

Model Number 1012455-12

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2022

Event Type  malfunction  

Event Description

It was reported that the 5.0x12mm nc trek balloon dilatation catheter (bdc) was prepared for use without issue and according to the instructions for use (ifu).The procedure was to treat a de novo lesion located in the left main that was moderately calcified.An unspecified stent was implanted and post-dilated.Intravascular ultrasound (ivus) showed the stent was well apposed to the vessel wall, but needed some post-dilatation.The nc trek was advanced to the stent without reported issue and successfully post-dilated the stent.During removal of the bdc, the distal tip of the balloon was stuck with the deployed stent but was able to be pulled back to the guide catheter, but unable to be pulled into the guide catheter.The entire system had to be removed as a unit.Although there was no reported inflation or deflation issue, when outside the patient, it was noticed that the shaft was kinked and the balloon was not fully deflated, as the distal tip of the balloon was not fully deflated.There was no reported adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

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

Event Description

Subsequent to the previously filed report, after the balloon was inflated and deflated, it wouldn't come out.Physician stated it was possibly stuck on stent struts.When he was finally able to pull it back out of the stent and towards the guide, it wouldn't come back into the guide.He had to remove the guide with the balloon from the body.When it was out of the body, the distal portion of the balloon was outside the guide and appeared to be under-deflated.That's why it wouldn't go into the guide.No additional information was provided.

Manufacturer Narrative

Visual, dimensional, and functional inspections were performed on the returned device.The reported deflation issue could not be confirmed; however, the reported kink was confirmed.The reported difficulty removing the device from the stent could not be replicated in a testing environment as it was based on operational circumstances.The reported difficulty removing the device from the guiding catheter could not be replicated in a testing environment due to the condition of the returned device.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 of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the reported difficulty removing the device and kink appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.Na.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13499017
• MDR Text Key: 288785866
• Report Number: 2024168-2022-01342
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152146
• UDI-Public: 08717648152146
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 1012455-12
• Device Catalogue Number: 1012455-12
• Device Lot Number: 10324G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2021
• 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 Age: 71 YR
• Patient Sex: Male
• Patient Weight: 74 KG