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

Model Number	1400350-15
Medical Device Problem Codes	Leak/Splash (1354); Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
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 the in the left circumflex with mild calcification.The 3.5x15mm nc trek neo balloon dilatation catheter (bdc) was successfully used the first time.However, the second time the bdc was advanced back into the non-abbott 0.014 190cm guidewire, a hole in the transition was noted and bleed back was coming back through the bdc.There was resistance felt advancing back into the guide wire.Another nc trek neo balloon was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the production records and the corrective and preventive actions (capa) was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot of specific issue.The investigation was unable to determine a conclusive cause for the reported difficulties.It was reported that when advancing the balloon dilation catheter (bdc), resistance was felt and a hole was noted.Factors that may contribute to difficulty advancing the balloon catheter over the guide wire include, but are not limited to, inner diameter of the catheter, outer diameter of the guide wire, device support, buildup of procedural contaminants, challenging anatomy, user technique, and/or damage to the catheter or guide wire.In this case, it is possible that the bdc interacted with the patient¿s mildly calcified lesion or an accessory device, contributing to the resistance.Manipulation of the bdc when resistance was encountered could result in damage to the balloon, such as torn material and a leak.Because the device was not returned for analysis, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D9, h3 - device returning status updated from yes to no.

• 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: 19554537
• Report Number: 2024168-2024-07307
• Device Sequence Number: 12445111
• Product Code: LOX
• UDI-Device Identifier: 08717648232633
• UDI-Public: (01)08717648232633(17)261231(10)40109G1
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 07/26/2024

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 Model Number: 1400350-15
• Device Catalogue Number: 1400350-15
• Device Lot Number: 40109G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2024
• 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 190CM GUIDEWIRE.
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 90 KG