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

Catalog Number	1012454-08
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot history 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.Possible factors that can contribute to difficult to remove/resistance with the guiding catheter post-inflation include, but are not limited to, loose balloon folds, guiding catheter lumen obstructions, kinks, bends or procedural technique.It was reported by the account that since resistance was met during attempts to remove the device, force was applied and the bdc separated.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: if resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.In this case, it is likely that the violation of the ifu contributed to the reported separation as the device separated after force was applied.The reported separation appears to be related to user error/operational context since resistance was met during attempts to remove the device and force was applied which likely resulted in the bdc separating.Based on the reported information and results of the complaint investigation, there is no indication that the reported difficulty removing the device from the guiding catheter or separation are related to a product quality issue with respect 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 right coronary artery that was 100% stenosed.After using nc trek rx 4.50 x 8mm balloon dilatation catheter, during withdrawal, resistance was felt with the guide catheter and the shaft separated in two pieces.The balloon was stuck in the front end of the guide catheter, and the broken section was withdrawn from the body together with the guide catheter with force, but no intervention required.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: NC TREK RX CORONARY DILATATION CATHETER
• Common Device Name: 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: 19139956
• Report Number: 2024168-2024-04858
• Device Sequence Number: 15578669
• Product Code: LOX
• UDI-Device Identifier: 08717648152092
• UDI-Public: (01)08717648152092(17)260131(10)30224G1
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103153
• 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): 04/18/2024

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 Expiration Date: 01/31/2026
• Device Catalogue Number: 1012454-08
• Device Lot Number: 30224G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2024
• Initial Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2023
• 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
• Patient Sex: Unknown