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

Model Number	1400300-15
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat the left anterior descending artery and the ramus interventricularis anterior (riva) artery.Two unspecified trek balloon dilatation catheters (bdc) and a nc trek neo bdc were noted to ruptured during the procedure.Then a 3.0x15mm nc trek neo bdc ruptured and became stuck in the riva.When attempting to remove the tip of the balloon separated, remaining in the vessel.A non-abbott stent was used to embed the separated portion.A non-abbott device was used to successfully complete the procedure.It was noted that there was an unspecified previously implanted stent that was under expanded, had a sharp edge that caused the bdc to rupture.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
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
Subsequent to the filed reports it was noted that the only three balloons were used 2.0x20mm trek, 3.0x12mm nc trek neo and a 3.0x15mm nc trek neo balloon catheters and were not soaked prior to use.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported separation was confirmed.The reported balloon rupture could not be confirmed due to the condition of the returned device.The reported difficulty removing the device could not be replicated in a testing environment as it is 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.It was reported that the device was not soaked prior to use.It should be noted that the coronary dilatation catheters (cdc), nc trek neo, instruction for use (ifu) states: submerge the balloon in sterile heparinized normal saline during balloon preparation, to activate the coating.In this case, it is unlikely that the ifu violation caused or contributed to the reported complaint.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported balloon rupture, difficulty to remove, separation, unexpected medical intervention and device embedded in tissue appear to be related to circumstances of the procedure.There was no leak noted during preparation, which suggests a product quality issue did not contribute to the reported difficulties.It was reported by the account that there was an unspecified previously implanted stent that was under expanded and had a sharp edge.In this case, it is likely that the balloon interacted with the previously implanted stent resulting in the reported balloon rupture during inflation.In addition, it is likely that the ruptured balloon material became stuck on the patient¿s anatomy, resulting in the reported difficulty removing the device and subsequently the balloon/tip ultimately separated.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: 23027701
• Report Number: 2024168-2025-09689
• Device Sequence Number: 13125318
• Product Code: LOX
• UDI-Device Identifier: 08717648232527
• UDI-Public: (01)08717648232527(17)271130(10)41214G1
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: 41214G1
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2024
• 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: Required Intervention
• Patient Sex: Unknown