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

Model Number	1400250-08
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
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.It was reported that resistance was noted when removing the protective sheath and the device was still used.It should be noted that the coronary dilatation catheters (cdc), nc trek neo, instruction for use (ifu) states: slide the protective sheath off the balloon by grasping the catheter just proximal to the balloon (at the proximal balloon bond site), and with the other hand, grasp the protective balloon sheath and gently remove distally.If unusual resistance is felt during product mandrel and sheath removal, do not use this product and replace with another.In this case, it is unknown if the ifu violation caused or contributed to the reported complaint.The investigation was unable to determine a conclusive cause for the reported difficulty removing the protective sheath; however, the reported balloon rupture appears to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.H6: 2017 improper or incorrect procedure or method - sheath removalna.
Event or Problem Description
It was reported that the procedure was to treat a 90% stenosed de novo lesion in the proximal left circumflex (plcx) artery with moderate calcification and mild tortuosity.Prior to use, the 2.50x8mm nc trek balloon dilatation catheter (bdc) was soaked in saline and the bdc was prepped (air aspiration) outside the anatomy.Resistance was noted when removing the protective sheath.The bdc was advanced to the lesion for pre-dilatation.The balloon was inflated twice to 10 atmospheres (atm); however, a balloon rupture occurred.The bdc was removed from the patient.A non-abbott balloon followed by stent implantation was performed to complete the procedure.There was no adverse patient effect and no clinically significant delay reported in procedure.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: 16872526
• Report Number: 2024168-2023-04743
• Device Sequence Number: 5832491
• 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): 05/04/2023

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: 04/12/2023
• Initial Report FDA Received Date: 05/04/2023
• 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
• Patient Sex: Unknown