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

Model Number	1400250-15
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
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 difficulty could not be determined.In this case, it is likely that the xience skypoint sds interacted with the nc trek neo bdc during advancement/manipulation due to the reduced clearance in the guiding catheter and became entangled with one another, resulting in the reported difficulty; however, since the devices were not returned for analysis, 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.The additional device referenced in b5 and d10 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat lesions in the left anterior descending (lad) and first diagonal arteries.After pre-dilatation with a non-abbott balloon, the 2.5x15mm nc trek neo balloon dilatation catheter (bdc) was advanced to the bifurcation of the lad; then the non-abbott balloon was removed.A 2.25x12mm xience skypoint stent delivery system (sds) was then attempted to be advance to the first diagonal; however, the sds became stuck in the guide catheter.Therefore, the guide wire, sds and bdc were removed with resistance.There was no adverse patient effect and no clinically significant delay reported in the procedure.

• 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 ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20886267
• Report Number: 2024168-2024-14444
• Device Sequence Number: 18402934
• Product Code: LOX
• UDI-Device Identifier: 08717648232411
• UDI-Public: (01)08717648232411(17)250430(10)20526G1
• Combination Product (Y/N): N
• 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): 12/09/2024

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 Expiration Date: 04/30/2025
• Device Model Number: 1400250-15
• Device Catalogue Number: 1400250-15
• Device Lot Number: 20526G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2022
• 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: 2.25X12MM XIENCE SKYPOINT STENT; 6FR INTRODUCER; 6FR XB 3.0 GUIDE CATHETER; RUNTHROUGH GUIDE WIRE
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Hispanic
• Patient Race: White