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

Model Number	1400300-15
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Serious Injury
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 performed was to treat a mildly calcified mid left anterior descending coronary artery that is 80% stenosed.During advancement of a 3.00x15mm nc trek neo balloon dilatation catheter (bdc), resistance was met with an unspecified nc trek neo balloon as both balloons were used to pre-dilate the lesion using the kissing balloon technique.During removal of the 3.00x15mm nc trek neo bdc, the shaft of the bdc separated and was removed with another unspecified guidewire by tangling it with the first guidewire.A new 3.0x15 nc trek neo was used to replace the first nc trek neo bdc and complete the procedure.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported separation was confirmed.The reported difficulty advancing the device could not be replicated in a testing environment as it was based on operational context.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, the investigation determined that the reported difficulty advancing the device, separation and unexpected medical intervention appear to be related to operational context.There was no damage noted to the device during the inspection prior to use, which suggests a product quality issue did not contribute to the reported difficulties.It was reported by the account that the device was used to perform the kissing balloon technique (kbt).It should be noted that when using two devices together or performing the kissing balloon technique (kbt), the access narrows through the guiding catheter due to the multiple devices inserted at once.When using two devices or performing the kbt it is recommended that the larger balloon be placed first and a larger size french (fr), like a 7fr guide be used.In this case, it is likely that the use of the kbt technique contributed to the reported difficulty during advancement.Return device analysis noted that the guide wire exit notch was torn longitudinally.The tearing of the guide wire exit notch appears to have resulted from an interaction with the guide wire.This type of mechanical damage can occur if an attempt is made to pull the catheter in an opposite direction as the guide wire.Additionally, the material at the noted separation was jagged which suggests that the separation may be related to tensile overload (material stress/fatigue).It is likely that the separation resulted from manipulation of the device during use as difficulty was encountered.Additional treatment was performed to remove the separated portion of the device.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
Subsequently to the initially filed report, it was noted that the unspecified nc trek neo was a 2.0x15mm nc trek neo bdc.The kissing balloon technique was not attempted again and the 2.0x15mm nc trek bdc was inflated in the diagonal branch.The 3.0x15mm nc trek neo was used for re-proximal optimization technique (re-pot).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: 22012047
• Report Number: 2024168-2025-04983
• Device Sequence Number: 5192301
• Product Code: LOX
• UDI-Device Identifier: 08717648232527
• UDI-Public: (01)08717648232527(17)280131(10)50210G1
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 07/09/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1400300-15
• Device Catalogue Number: 1400300-15
• Device Lot Number: 50210G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• 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 Age: 58 YR
• Patient Sex: Male
• Patient Weight: 80 KG