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

Catalog Number	1400400-15
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported balloon rupture; however, the reported unexpected medical intervention appears to be related to circumstances of the procedure.The reported patient effect of dissection is listed in the coronary dilatation catheters (cdc), nc trek neo, instruction for use as a known patient effect.A conclusive cause for the reported patient effect of vascular dissection and the relationship to the device, if any, cannot be determined.The additional nc trek neo device referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
The procedure was to treat a lesion in the right coronary artery (rca).For pre-dilatation, a 4.0x15mm nc trek neo balloon dilatation catheter (bdc) was used; however, the balloon ruptured at 15 atmospheres (atm) during the first inflation.Therefore, the bdc was removed from the patient and a dissection was noted.Therefore, a 4.0x33mm xience stent was implanted without issue to treat the dissection.Then, a 4.5x12mm nc trek neo bdc was used for post dilatation; however, the balloon ruptured at 18 atm.The 4.5x12mm nc trek neo was removed from the patient and another same size nc trek neo balloon was used to complete the procedure.There was no adverse patient sequela.No additional information was provided.

• 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: 18348365
• Report Number: 2024168-2023-14169
• Device Sequence Number: 6202265
• 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
• Report Date (Section B): 12/18/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: 1400400-15
• Device Lot Number: 30609G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2023
• 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: Required Intervention
• Patient Sex: Unknown