MAUDE Adverse Event Report: ABBOTT VASCULAR INC. NC TREK NEO¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	1400250-15
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
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 calcified lesion in the left anterior descending (lad) artery.The 2.5x15mm nc trek balloon dilatation catheter (bdc) was used in the procedure; however, the balloon ruptured.The bdc became stuck with the wire and the tip of the balloon became torn.There was no adverse patient effect and no clinically significant delay reported in the procedure.A non-abbott balloon was used to continue the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initial report being filed, it was reported that the balloon dilatation catheter (bdc) met with resistance during initial advancement with the guide wire (gw) outside the patient anatomy.Therefore, the bdc was removed from the gw and the bdc and the gw were noted to be stuck together.Force was applied to free the bdc; however, part of the balloon remained stuck to the gw.A blade was used outside the patient to remove the part of the balloon that was stuck to the gw.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.It was reported that the nc trek neo bdc experienced resistance with the guide wire during advancement and removal as a result of the contrast that remained on the guide wire.Force was applied against the noted resistance and the balloon separated onto the guide wire.It should be noted that the coronary dilatation catheters (cdc), nc trek neo, instructions for use stated: if resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.Force was applied against the noted resistance and the balloon separated onto the guide wire.Based on the information received, the investigation determined that the reported difficulty advancing and removing the device from the guide wire appears to be related to operational context; however, the reported separation appears to be related to user error/operational context.It was reported by the account that the balloon dilatation catheter (bdc) experienced resistance with the guide wire during advancement and removal as a result of the contrast that remained on the guide wire.Based on the results of the complaint investigation, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: NC TREK NEO¿
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 20485285
• Report Number: 2024168-2024-12295
• Device Sequence Number: 11642659
• Product Code: LOX
• UDI-Device Identifier: 08717648232411
• UDI-Public: (01)08717648232411(17)260531(10)30613G1
• Combination Product (Y/N): N
• 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): 11/15/2024

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: 05/31/2026
• Device Model Number: 1400250-15
• Device Catalogue Number: 1400250-15
• Device Lot Number: 30613G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2023
• 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
• Patient Sex: Unknown