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

Model Number	1400350-12
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a mildly calcified and heavily tortuous lesion in the left anterior descending (lad) artery.Following the deployment of two non-abbott stents, a 3.5x12mm nc trek neo balloon dilatation catheter (bdc) was advanced to the lesion, using the kissing method, through resistance and used to post-dilate the two non-abbott stents.However, following post-dilatation to nominal pressure six times, the bdc was completely deflated; however, resistance was felt during withdrawal and the hypotube of the bdc was noted to separate.At this time an attempt to remove the separated hypotube was made using a snare and a non-abbott bdc; however, the non-abbott bdc was also noted to separate.Therefore, the patient was sent to undergo surgery to surgically remove the 2 separated bdc's.A clinically significant delay was reported; however, there was no adverse patient sequela.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 query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the information received, the investigation determined that the reported separation, difficulty advancing and removing the device form the anatomy, delay to treatment, surgical intervention, unexpected medical intervention and hospitalization 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 balloon dilatation catheter (bdc) interacted with the mildly calcified and heavily tortuous anatomy resulting in the reported difficult advancing and removing the device from the anatomy.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.In this case, it is likely that the combination of the patient¿s challenging anatomy and the use or the kbt technique contributed to the reported difficulties during advancement and removal of the device and subsequently the shaft ultimately separated due to the manipulation.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 UNK ; CS UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21968327
• Report Number: 2024168-2025-04691
• Device Sequence Number: 12790272
• Product Code: LOX
• UDI-Device Identifier: 08717648232626
• UDI-Public: (01)08717648232626(17)270831(10)40913G1
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 05/06/2025

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: 1400350-12
• Device Catalogue Number: 1400350-12
• Device Lot Number: 40913G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Unknown