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

Model Number	1400450-12
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified lesion in the proximal left anterior descending (plad) artery.The 4.5x12mm nc trek neo balloon dilatation catheter (bdc) and the ht bmw universal ii 190cm guide wire (gw) were used in the procedure; however, the bdc and gw became stuck together.Therefore, the bdc and gw were removed as a single unit and the gw was noted to have separated.There was no adverse patient effect reported and no clinically significant delay reported 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.The additional device referenced in b5 is filed under a separate medwatch report number.
Additional Manufacturer Narrative
Visual, dimensional, and functional analysis were performed on the returned device.The reported difficulty removing the guide wire from the balloon catheter could not be confirmed.Production record and corrective and preventive 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 results of the complaint investigation there is no indication the reported difficulty removing the device from the guide wire is related to a potential product quality issue.Possible factors that may contribute to the difficult removing the guide wire causing resistance between the devices may include, but not limited to, procedural contaminant buildup in the guide wire lumen, 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 complaint cannot be determined since the reported difficulty could not be confirmed during return analysis and the guide wire was not returned for analysis.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 being filed, it was reported that nc trek neo balloon was inflated once to 18 atmospheres (atm) and the balloon was fully deflated prior to attempted removal.The guide wire tip had separated in 2 pieces while inside the guiding sheath; however, the guide wire was able to be removed.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 ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 19512140
• Report Number: 2024168-2024-06898
• Device Sequence Number: 3554637
• Product Code: LOX
• UDI-Device Identifier: 08717648232756
• UDI-Public: (01)08717648232756(17)260630(10)30727G1
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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: 06/30/2026
• Device Model Number: 1400450-12
• Device Catalogue Number: 1400450-12
• Device Lot Number: 30727G1
• 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: 05/23/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2023
• 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: HT BMW UNIVERSAL II 190CM GUIDE WIRE
• Patient Sex: Unknown