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

Model Number	1400350-08
Medical Device Problem Codes	Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cardiac ablation procedure was to treat a lesion in the mid right coronary artery (mrca) with 90% stenosis, heavy calcification and moderate tortuosity.A 3.25x15mm xience skypoint stent was implanted.The 3.5x8mm nc trek neo balloon dilatation catheter (bdc) had resistance during advancement with the lesion and was used for post dilatation per standard procedure when the balloon ruptured during the first inflation at 6 atmospheres (atms).Another same size non-abbott balloon was used to perform additional dilation several times and the procedure was completed.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) database 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 specific issue.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.It was reported that the balloon dilation catheter interacted with the patient¿s heavily calcified, moderately tortuous, and 90% lesions during advancement, resulting in the reported difficulty during advancement.Additionally, it was reported that the balloon ruptured during inflation.It is likely that the interaction with the anatomy, during advancement, compromised the balloons integrity, contributing to the reported material rupture.It should also be noted that there was no leak noted during preparation or during the first inflation, which suggests a product quality issue did not contribute to the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 20088040
• Report Number: 2024168-2024-10177
• Device Sequence Number: 7599550
• Product Code: LOX
• UDI-Device Identifier: 08717648232619
• UDI-Public: (01)08717648232619(17)270131(10)40212G1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 08/28/2024

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: 1400350-08
• Device Catalogue Number: 1400350-08
• Device Lot Number: 40212G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2024
• 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: 3.25X15MM XIENCE SKYPOINT STENT
• Patient Sex: Unknown