MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK NEO RX; NC TREK NEO CORONARY DILATATION CATHETER

Catalog Number	1400400-12
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2024
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.
Event or Problem Description
It was reported that the procedure was to treat a lesion in an unspecified artery and during use of a 4.0x12mm nc trek neo balloon dilatation catheter, the balloon separated from the delivery system.Medical intervention was not reported.Another balloon was used to complete the procedure.There was no adverse patient sequelae and there was no clinically significant delay 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.B1 - adverse event/product problem: adverse event was removed.B2 - outcomes attributed to ae: updated from other serious to na.B6 - relevant test/laboratory data updated.B7 - other relevant history updated.H1 - type of reportable event: updated from serious injury to malfunction.H6 - health effect - clinical code 2687 removed and 4582 added; health effect - impact code 4614 removed and 2645 added.
Event or Problem Description
It was reported that the procedure was to treat a lesion in an unspecified artery and during use of a 4.0x12mm nc trek neo balloon dilatation catheter, the balloon separated from the delivery system.Medical intervention was not reported.Another balloon was used to complete the procedure.There was no adverse patient sequelae and there was no clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was provided: the bdc was being prepared when the balloon separated from the catheter upon removal of the protective sheath.The separated portion was found on the sterile table.There was no patient involvement.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported separation was confirmed.The electronic lot history record (elhr) and corrective and preventive 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 no other similar complaints from this lot.The investigation determined the reported separation appears to be related to operational context.Returned device analysis noted the outer member separated proximal to the guide wire exit notch.The material at the noted separation was jagged which suggests that the separation may be related to tensile overload (material stress/fatigue).In this case, it is likely that the device was inadvertently mishandled during removal of the protective sheath and/or mandrel/stylet resulting in the reported separation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: NC TREK NEO RX
• Common Device Name: NC TREK NEO CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 18874818
• Report Number: 2024168-2024-03094
• Device Sequence Number: 7950916
• Product Code: LOX
• UDI-Device Identifier: 08717648232718
• UDI-Public: (01)08717648232718(17)260930(10)31004G1
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• 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,Followup,Followup
• Report Date (Section B): 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: 1400400-12
• Device Lot Number: 31004G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 03/19/2024; 04/29/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 03/21/2024; 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown