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

Catalog Number	1400400-08
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6 medical device problem code: 2017- excessive force.
Event or Problem Description
It was reported that the procedure was to treat a previously implanted 3.0x28mm xience stent that was noted to have 80% thrombus the lesion.The 4.0x8mm nc trek neo balloon dilatation catheter was inflated; however, would not deflate.After multiple attempts were made to deflate the balloon, the balloon wire and catheter were drawn back to the right upper extremity from the right radial access site.More attempts were made to rupture and deflate the balloon using over pressure and end wire puncture with the balloon drawn back to the tip of the guide.Ultimately successful retrieving an intact balloon using those methods and drawing the balloon into the guide with negative pressure on the balloon with forceful aspiration through the guide lumen.There was no adverse patient sequela reported and no clinically significant delay reported.No additional information was provided.
Event or Problem Description
Subsequently, after the initial report was filed it was noted that 3.0x28mm xience stent mentioned was treating the lesion that was already thrombus and was successfully implanted.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported failure to deflate and difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.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 of the reported lot did not indicate a lot specific quality issue.It was reported by the account that the balloon had to be removed partially inflated and with force.It should be noted that the coronary dilatation catheters (cdc), nc trek neo, instruction for use (ifu,) states: do not advance or retract the catheter unless the balloon is fully deflated under vacuum.The warning section stated: 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 ifu violation of removing the balloon partially inflated contributed to the reported difficulty removing the device and subsequently force had to be use.Additionally, it was reported that the balloon was inflated over pressure in an attempt to rupture the balloon and remove it from the anatomy as failure to deflate was noted.The 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.In this case, the reported ifu violation did not cause or contribute to the reported complaints as the balloon did not rupture and was overinflated in an attempt for additional treatment.The investigation was unable to determine a conclusive cause for the reported failure to deflated; however, the reported difficulty removing the device and unexpected medical intervention 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.

• 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: 18080833
• Report Number: 2024168-2023-12312
• Device Sequence Number: 6789184
• Product Code: LOX
• UDI-Device Identifier: 08717648232701
• UDI-Public: 08717648232701
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: 1400400-08
• Device Lot Number: 21012G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 3.0X28MM XIENCE STENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown