MAUDE Adverse Event Report: ABBOTT VASCULAR INC. NC TREK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	1012454-20
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Non specific EKG/ECG Changes (1817)
Date of Event	09/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the right coronary artery (rca) ostium with mild calcification, no tortuosity and 70% stenosis.An unspecified stent was implanted and post dilation was performed by the 4.5x20mm non-compliant (nc) trek balloon dilatation catheter (bdc).The balloon was inflated twice to 16 atmospheres (atm).Upon deflation, the device was held negative for a normal amount of time; however, the balloon only deflated about 20% and remained stuck in the coronary artery.Two attempts to deflate the balloon with two different non-abbott inflation device, before resorting to manual deflation with a syringe.The patient experienced a temporary inferior st elevation which resolved itself upon device removal.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: medical device problem code 2017- contrast incorrect.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.It was reported that the contrast mix used in the procedure was 60/40 saline/contrast.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global instructions for use (ifu) specified that the contrast is 60% contrast medium diluted 1:1 with normal saline.In this case, since a 60% saline to 40% contrast ration was used and is less contrast concentration than the required percentage, it is unknown if the ifu violation caused or contributed to the reported complaint.Based on the information provided, a definitive cause for the reported deflation issue could not be determined; however, the reported difficulty removing the device and unexpected medical intervention appear to be related to circumstances of the procedure.A conclusive cause for the reported patient effects of non-specific ekg/ecg changes and the relationship to the device, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: NC TREK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 20516620
• Report Number: 2024168-2024-12464
• Device Sequence Number: 21008010
• Product Code: LOX
• UDI-Device Identifier: 08717648152122
• UDI-Public: (01)08717648152122(17)250630(10)20701G1
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K110134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: 1012454-20
• Device Catalogue Number: 1012454-20
• Device Lot Number: 20701G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TWO NON-ABBOTT INFLATION DEVICES; UNSPECIFIED STENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown