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

Model Number	1400250-08
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a de novo lesion in the left anterior descending (lad) artery with 75% stenosis, heavy calcification and mild tortuosity.A 2.5x12mm non-abbott stent was implanted in the distal lad.The 2.5x8mm nc trek neo balloon dilatation catheter (bdc) was soaked in saline and prepared (air aspiration) outside the anatomy prior to use.There was no resistance during advancement and was dilated at the proximal site of the implanted stent when the balloon ruptured during the first inflation at 22 atmospheres (atms).Cine confirmed the contrast leak.There was no resistance during removal.Another non-abbott balloon was used to continue the procedure and intravascular ultrasound (ivus) was performed.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
H6: medical device problem code 2017 - above rbp.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 of the reported lot did not indicate a lot specific quality issue.It was reported that the balloon was inflated to 22 atmospheres.It should be noted that the coronary dilatation catheters (cdc), nc trek neo, instructions for use (ifu) warning section, states: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the nc trek neo device is 18 atm; therefore, rbp was exceeded.It could not be determined if inflating the balloon slightly over the rated burst pressure contributed to the rupture, the investigation determined the reported difficulty appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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: 17050300
• Report Number: 2024168-2023-05792
• Device Sequence Number: 6965603
• Product Code: LOX
• UDI-Device Identifier: 08717648232398
• UDI-Public: 08717648232398
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2023

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: 04/30/2025
• Device Model Number: 1400250-08
• Device Catalogue Number: 1400250-08
• Device Lot Number: 20524G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2022
• 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: ONYX 2.5X12MM
• Patient Sex: Unknown