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

Catalog Number	1012453-15
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the distal common trunk/left anterior descending (lad) with 99% stenosis (spontaneous dissection is the probable cause).The nc trek rx balloon dilatation catheter (bdc) had no resistance during advancement and was inflated 3 times.Negative was held 5-10 seconds for each inflation.The balloon was fully deflated; however, there was resistance with the guiding catheter and was ultimately withdrawn as a single unit.However, separation of the balloon occurred and parts of the balloon were in the common trunk/lad which led to thrombosis which was confirmed by angiography.Thrombosis was treated with medication.The patient was sent to cardiac surgery to assess the patient's condition and to intervene if needed.The patient underwent a double aortocoronary bypass and the material remaining in the coronary artery was removed via a transaortic approach.Nothing remains in the anatomy.Patient was hemodynamically stable and is in cardiologic rehabilitation.There was no adverse patient sequelae and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported separation was confirmed.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.The electronic lot history record (elhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.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 difficulty removing the device; however, the reported separation, medication required, surgical intervention and hospitalization appear to be related to circumstances of the procedure.Possible factors that can contribute to difficult to remove/resistance with the guiding catheter post-inflation include, but are not limited to, loose balloon folds, guiding catheter lumen obstructions, kinks, bends, procedural technique, insufficient support or interactions with other devices.Additionally, it is likely that the bdc was inadvertently mishandled during removal, as resistance was encountered, resulting in the reported separation.A conclusive cause for the reported patient effect of thrombosis and the relationship to the device, if any, cannot be determined.Based on the reported information, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Correction: d4 - lot # updated from 21027g2 to 20611g1.Correction: d4 - catalog # updated from 1012454-08 to 1012453-15.

• Brand Name: NC TREK RX 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: 18905842
• Report Number: 2024168-2024-03331
• Device Sequence Number: 12742556
• Product Code: LOX
• UDI-Device Identifier: 08717648152078
• UDI-Public: (01)08717648152078(17)250531(10)20611G1
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2024

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: 05/31/2025
• Device Catalogue Number: 1012453-15
• Device Lot Number: 20611G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female