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

Catalog Number	1012452-12
Medical Device Problem Codes	Inflation Problem (1310); Stretched (1601); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported inflation issue was not confirmed.The inner and outer member were stretched distal to the mid lap seal possibly due to inadvertent mishandling of the device; however, it is unknown when these damages occurred.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 not soaked prior to use.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: submerge the balloon in sterile heparinized normal saline during balloon preparation, to activate the coating.In this case, it is unknown if the violation of the ifu caused or contributed to the reported complaint.The investigation was unable to determine a conclusive cause for the reported inflation issue or noted stretched inner and outer member.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.H6; device code 2017 clarifier - incorrect prepna.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified, moderately tortuous proximal left anterior descending artery.The 3.75x12mm nc trek balloon dilatation catheter (bdc) failed to inflate after repeated attempts for post dilatation at 14 atmospheres.It was noted the bdc would hold pressure; however, would not inflate.The device was not soaked prior to use.Another 3.75x12mm was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay reported.Device analysis noted that the shaft of the bdc was stretched distal to the mid lap seal.No additional information was provided.

• Brand Name: NC TREK 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: 18107852
• Report Number: 2024168-2023-12487
• Device Sequence Number: 6004356
• Product Code: LOX
• UDI-Device Identifier: 08717648152023
• UDI-Public: 08717648152023
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 11/09/2023

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: 07/31/2025
• Device Catalogue Number: 1012452-12
• Device Lot Number: 20830G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2022
• 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