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

Model Number	1400200-12
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device problem code 2017-above rated burst pressure.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.It was reported that the balloon was inflated to 20 atmospheres.It should be noted that the coronary dilatation catheters, nc trek neo, instruction for use (ifu) states: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the nc trek neo device is 18 atm; therefore, rbp was exceeded.It could not be determined if inflating the balloon slightly over the rbp contributed to the rupture.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the distal right coronary artery that was moderately tortuous, heavily calcified and 90% stenosed.Reportedly, the nc trek neo rx 2.00 x 12mm balloon dilatation catheter (bdc) ruptured at 20 atmospheres during the first inflation.The inflation time was for 20 seconds.Reportedly there was resistance advancing and removing the bdc.A cutting balloon was used to complete the procedure.There was no adverse patient effect.No additional information was provided.

• 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: 17026712
• Report Number: 2024168-2023-05657
• Device Sequence Number: 3479817
• Product Code: LOX
• UDI-Device Identifier: 08717648232305
• UDI-Public: 08717648232305
• 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): 05/30/2023

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: 05/31/2025
• Device Model Number: 1400200-12
• Device Catalogue Number: 1400200-12
• Device Lot Number: 20620G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• 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