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

Model Number	1400250-15
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
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 was to treat a distal left main (lm), left anterior descending artery and the circumflex artery that is heavily calcified.The 2.50x15mm nc trek neo balloon dilatation catheter (bdc) would not fully deflate noted by the images provided.When attempting to remove the bdc through the guiding catheter resistance was met with a previously implanted stent.The bdc became stuck and separated.The previously implanted stent and stuck bdc had to were removed together.The separated portion of the bdc was snared out with the entire system as the snare device became stuck in the radial sheath.The lesion was re-stented with new unspecified stents, unspecified balloon, unspecified wires and unspecified guiding catheter to complete the procedure.There was no adverse patient sequela and no clinically significant delay in the procedure.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.Based on the information provided, a definitive cause for the reported complaints could not be determined; however, the reported unexpected medical intervention appears to be related to circumstances of the procedure.Possible factors that may contribute to difficulty deflating the balloon include, but are not limited to, deflation technique, tortuous anatomy, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.In this case, it is possible that the calcification or partial deflation and early retraction contributed to the reported difficulty removing the device and upon further manipulation the device ultimately separated; however, a conclusive cause cannot be determined.Additionally, it is possible that the nc trek was impacted by the proximal edge of the stent.If the stent system was not fully opened causing the proximal end to be coned in, that may have been damaged by the stent; however, a conclusive cause cannot be determined.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 report filed it was noted that the separation of the nc trek neo was at the wire exit point.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: 21921287
• Report Number: 2024168-2025-04385
• Device Sequence Number: 13019435
• Product Code: LOX
• UDI-Device Identifier: 08717648232411
• UDI-Public: (01)08717648232411(17)270930(10)41010G1
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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: 1400250-15
• Device Catalogue Number: 1400250-15
• Device Lot Number: 41010G1
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2024
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 76 KG