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

Model Number	1012453-15
Medical Device Problem Codes	Deflation Problem (1149); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the procedure was performed to treat a lesion in the circumflex (cx) into left mail (lm) with heavy calcification and mild tortuosity.The nc trek balloon catheter was advanced to the target lesion and inflated to 10 atmospheres (atm) and deflated without issue, and removed from the patient.After stent implantation, the balloon was re-advanced to the stented lesion.The balloon was inflated 4 more times to 10atm, but after the fourth inflation, the balloon failed to deflate.Multiple attempts to deflated the balloon with an indeflator were unsuccessful.Additionally a syringe was used to deflate the balloon.The balloon was pulled inflated into the aorta and was either partially or completed deflated in the aorta, then was able to be removed from the patient.There was no adverse patient effect and no clinically significant delay in the procedure.No additioinal information was provided.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
H6: medical device problem code 2017- incorrect removal.Visual, dimensional and functional inspections were performed on the returned device.The reported deflation issue could not be 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/complaints from this lot.It was reported that the balloon was pulled inflated into the aorta.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use states: withdraw the deflated dilatation catheter and guide wire from the guiding catheter through the hemostatic valve.In this case, it is unlikely that the reported violation caused or contributed to the reported complaint.The investigation was unable to determine a conclusive cause for the reported deflation issue.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• 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: 16492108
• Report Number: 2024168-2023-02285
• Device Sequence Number: 20485938
• Product Code: LOX
• UDI-Device Identifier: 08717648152078
• UDI-Public: 08717648152078
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/12/2023

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: 09/30/2025
• Device Model Number: 1012453-15
• Device Catalogue Number: 1012453-15
• Device Lot Number: 21012G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2022
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 45 KG