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

Model Number	1400300-08
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
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.D4: the udi number is not known as the part and lot number were not provided.The additional device referenced in b5 are filed under separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the circumflex (cx) artery.For post dilatation, during advancement of the 3x8mm nc trek balloon dilatation catheter (bdc) on a ht bmw universal ii guide wire (gw), resistance was noted and the gw became separated in 2 pieces.Resistance was noted between the gw and bdc during removal; therefore, the separated portion of the gw was removed with the bdc and the other portion of the gw was able to be simply removed.It was noted the guide wire exit notch, the inner and the outer member of the bdc were torn.No post dilatation was performed in the procedure.There was no adverse patient effect reported and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection and functional testing were performed on the returned device.The reported tears were confirmed.The reported difficulty advancing and removing the device from the guide wire could not be replicated in a testing environment due to the condition of the returned device.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.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported difficulty advancing and removing the device from the guide wire could not be determined; however, the reported tears appear to be related to operational context.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
Subsequent to the initial report being filed, it was reported that the balloon dilatation catheter (bdc) was a 3x8mm nc trek neo balloon dilatation catheter (bdc).No additional information was provided.

• 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 UNK ; CS UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 22177645
• Report Number: 2024168-2025-05970
• Device Sequence Number: 9520318
• Product Code: LOX
• UDI-Device Identifier: 08717648232503
• UDI-Public: (01)08717648232503(17)271031(10)41130G1
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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 Model Number: 1400300-08
• Device Catalogue Number: 1400300-08
• Device Lot Number: 41130G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2024
• 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: HT BMW UNIVERSAL II 190CM.
• Patient Sex: Unknown