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

Model Number	1400350-20
Medical Device Problem Codes	Break (1069); Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.Return device analysis noted there was one kink in the dispenser coil, a kink in the hypotube located at the distal end of strain relief and a break in the hypotube, distally from distal end of strain relief.The hypotube was kinked at same location of the noted kinked ring of dispenser coil when coiled.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, a definitive cause for the noted damage on the returned device could not be determined.Return device analysis noted there was one kink in the dispenser coil, a kink in the hypotube located at the distal end of strain relief and a break in the hypotube, distally from distal end of strain relief.The proximal and distal break points were oval and jagged which can indicate the hypotube was kinked.The hypotube was kinked at same location of the noted kinked ring of dispenser coil when coiled.Potential factors that may contribute to kink damage to the balloon dilatation catheter (bdc) and dispenser coil include, but are not limited to, mishandling during manufacturing, during receiving/storage at the account, and/or handling during removal from packaging or preparation.In this case, it is possible that the device was damaged (kinked) during receiving at the account and/or during unpackaging and upon further manipulation at the kink location the hypotube broke; 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.B5: date of event is estimated.
Event or Problem Description
It was reported that the 3.5x20 mm nc trek neo balloon dilatation catheter (bdc) was noted to be damaged upon unpackaging of the device.There was no reported device use or patient involvement.There was no reported clinically significant delay in the procedure.Returned device analysis identified that there was a break in the hypotube.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.Return device analysis noted there was one kink in the dispenser coil, a kink in the hypotube located at the distal end of strain relief and a break in the hypotube, distally from distal end of strain relief.The hypotube was kinked at same location of the noted kinked ring of dispenser coil when coiled.A production record review was performed and revealed no indication of a product quality issue.A review of the complaint history identified no other similar complaints from this lot.A corrective and preventative action (capa) review was performed and determined there is an open capa issue related to this complaint; indicating there is a potential product quality issue.The investigation determined a potential product quality issue based on the evaluation of the returned unit and the review of the corrective and preventative actions (capa) database.Additionally, it is likely that the noted kink and break on the hypotube resulted from the kink on the coil.H6: investigation findings code 114 was removed.H6: investigation conclusions code 4315 was removed.H11: additional mfg narrative: revised.

• 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: 22739216
• Report Number: 2024168-2025-08184
• Device Sequence Number: 15251124
• Product Code: LOX
• UDI-Device Identifier: 08717648232640
• UDI-Public: (01)08717648232640(17)270430(10)40515G1
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 02/25/2026

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 Model Number: 1400350-20
• Device Catalogue Number: 1400350-20
• Device Lot Number: 40515G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• 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
• Patient Sex: Unknown