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

Catalog Number	1012453-15
Medical Device Problem Codes	Failure to Fold (1255); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat the proximal right coronary artery (rca).A stent was implanted in the rca and the 4.0x15 mm nc trek was used for post dilatation; however, there was resistance when removing the stylet/protective sheath.The balloon was not prepped (air aspiration) outside the anatomy prior to use and the contrast mix was normal saline.The nc trek balloon was inflated once during the procedure, to 12 atmospheres (atm) for 9 seconds.Negative pressure was held for 2 seconds.The tip of the balloon was wrinkled and the balloon was stuck in the stent.After repeated attempts, the balloon was able to be removed independently, but there was rewrap issues and the balloon was corkscrewed.After the procedure the balloon was inflated again to 12 atm for 4 seconds to see if it would work.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported failure to fold, twisted balloon and difficulty removing the stylet/mandrel from the device could not be confirmed.The reported difficulty removing the protective sheath could not be replicated in a testing environment because the protective sheath was not returned for analysis.The reported difficulty removing the device from the stent could not be replicated in a testing environment as it was based on operational circumstances.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 device was not prepped outside of the patient anatomy.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use specifies: all air must be removed from the balloon and displaced with contrast prior to inserting into the body, otherwise, complications may occur.In this case, it is unknown if the violation of the ifu caused or contributed to the reported complaint.Additionally, it was reported that the contrast mix used in the procedure was normal saline.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global instructions for use specifies that the contrast is 60% contrast medium diluted 1:1 with normal saline.In this case, since only normal saline was used and is less contrast concentration than the required percentage, it is unknown if the ifu violation caused or contributed to the reported complaint.The investigation was unable to determine a conclusive cause for the reported complaints.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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: 18240151
• Report Number: 2024168-2023-13259
• Device Sequence Number: 3201572
• Product Code: LOX
• UDI-Device Identifier: 08717648152078
• UDI-Public: 08717648152078
• 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,Followup
• Report Date (Section B): 03/07/2024

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: 04/30/2026
• Device Catalogue Number: 1012453-15
• Device Lot Number: 30525G1
• 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: 11/09/2023
• Supplement Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2023
• 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