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

Catalog Number	1400400-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The incident information was reviewed; however, there was no reported device malfunction, and the product was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined.The reported patient effect of vascular dissection is listed in the coronary dilatation catheters (cdc), nc trek neo, instruction for use (ifu) as a known patient effect.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the lad with moderate calcification.After a non-abbott stent was implanted, the 4.0x15mm nc trek neo balloon dilatation catheter (bdc) was used for post dilatation and a proximal dissection was noted on optical coherence tomography (oct).The dissection was left untreated.There were no adverse patient effects and no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
Nag3 - date received by mfg: initial date was 10/24/2023.

• Brand Name: NC TREK NEO RX
• Common Device Name: NC TREK NEO 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: 18136018
• Report Number: 2024168-2023-12643
• Device Sequence Number: 6449158
• Product Code: LOX
• UDI-Device Identifier: 08717648232725
• UDI-Public: 08717648232725
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K220634
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: 1400400-15
• Device Lot Number: 30522G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2023
• 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: Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 72 KG