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

Model Number	1012455-15
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: medical device problem code 2017 - incorrect prep.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right coronary artery (rca) with 90% stenosis, moderate calcification and mild tortuosity.The 5.0x15mm nc trek balloon dilatation catheter (bdc) was not prepared or flushed per instruction for use (ifu) and was used successfully; however, the balloon got stuck in the guide wire during removal and removed as a single unit losing radial access.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported separation was confirmed.The reported difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.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.It was reported by the account that the device was not prepped (air aspirated) or flushed.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states to flush the device and perform air aspiration prior to inserting in the body, otherwise complications may occur.In this case, it is unknown if the reported violation of the ifu caused or contributed to the complaint.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported difficulty removing the device could not be determined; however, the reported separation appears to be related to operational context.Possible factors that may contribute to the difficult to remove the balloon dilatation catheter (bdc) from the guide wire causing resistance between the devices may include, but not limited to, manufacturing damage, inner diameter of guide wire lumen, condition of the guide wire, or damage to the distal shaft of the catheter.In this case, a conclusive cause for the reported difficulty could not be determined.Furthermore, it is likely that the shaft separated during removal as resistance was encountered with the guide wire.Based on the results of the complaint investigation 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 previous filed report, it was noted that the outer member and inner member separated when attempting to remove the nc trek balloon dilatation with the unspecified guide wire.It was noted that the separated portion was simply withdrawn.No additional information was provided.

• Brand Name: NC TREK
• 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: 21448348
• Report Number: 2024168-2025-02019
• Device Sequence Number: 15252852
• Product Code: LOX
• UDI-Device Identifier: 08717648152153
• UDI-Public: (01)08717648152153(17)270331(10)40417G1
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K110134
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1012455-15
• Device Catalogue Number: 1012455-15
• Device Lot Number: 40417G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 0.014"X190CM GUIDE WIRE.
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 72 KG
• Patient Ethnicity: Hispanic
• Patient Race: White