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

Catalog Number	1012453-08
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: device code 2017 - incorrect prep.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the left anterior descending (lad) coronary artery with mild calcification.After an unspecified stent was placed.The 4.0x8.0mm nc trek balloon dilatation catheter (bdc) was not soaked prior to use and was introduced to post dilate the lesion.Under fluoroscopy a leak was noted at the distal tip of the balloon when was inflated once to 12 atmospheres and did not hold pressure.Therefore, by using an indeflator continuously to inflate the balloon, it was possible to post dilate the lesion to 4 mm and complete the procedure.The device was removed as a single unit and pressurized to confirm the balloon leak.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual, functional and scanning electron microscopy (sem) inspections/analysis were performed on the returned device.The reported leak was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.It was reported that the balloon was not soaked prior to use.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use states: submerge the balloon in sterile heparinized normal saline during balloon preparation, to activate the coating.In this case, it is unknown if the violation of the ifu caused or contributed to the reported complaint.The investigation was unable to determine a conclusive cause for the reported leak.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.H6 - device code 1546 removed and 1354 was added.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: 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: 17633566
• Report Number: 2024168-2023-09371
• Device Sequence Number: 12380462
• Product Code: LOX
• UDI-Device Identifier: 08717648152054
• UDI-Public: 08717648152054
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Catalogue Number: 1012453-08
• Device Lot Number: 21216G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown