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

Model Number	1400300-06
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified, heavily tortuous proximal right coronary artery that is 100% stenosed.The 1.5x12mm mini trek balloon dilatation catheter was advanced to the lesion with resistance felt with anatomy; however, during the first inflation the balloon ruptured at 8 atmospheres (atm).Additional pre-dilatation was performed with a 1.2x6mm mini trek.After a 3.0x12mm trek balloon dilatation catheter was used for dilatation, but the balloon ruptured during first inflation at 6 atms.It was noted resistance was felt with anatomy during advancement of the 3.0x12mm trek.A 3.0x6mm nc trek balloon was attempted to be used, but ruptured at the third inflation at 10 atms.Another unspecified balloon was used to continue the procedure.There was no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.The 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.The investigation determined that the reported balloon rupture appears to be related to operational context.There was no leak noted during preparation or during the first two inflations, which suggests a product quality issue did not contribute to the reported difficulty.In this case, it is likely that the balloon interacted with the heavily calcified anatomy such that the balloon became damaged and subsequently ruptured during third inflation.Based on the reported information, 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¿
• 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: 20453224
• Report Number: 2024168-2024-12137
• Device Sequence Number: 20610732
• Product Code: LOX
• UDI-Device Identifier: 08717648232497
• UDI-Public: (01)08717648232497(17)270331(10)40416G1
• 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): 10/15/2024

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: 1400300-06
• Device Catalogue Number: 1400300-06
• Device Lot Number: 40416G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2024
• 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
• Patient Sex: Unknown