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

Model Number	1012454-20
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rdc 2017 - improper or incorrect procedure or method - incorrect prep and contrast incorrect 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 right coronary artery (rca).The 4.5x20 mm nc trek balloon dilatation catheter was not prepped (air aspiration) outside the anatomy prior to use.There was no difficulty removing the protective sheath.The contrast mix was 50ml contrast and 20ml saline.The balloon was advanced and inflated once at a pressure of 14 atmospheres (atms).Negative was held for 5 seconds to deflate the balloon.However, the balloon had poor deflation and the device was stuck in the patient.The balloon partially deflated but was ultimately removed fully deflated with the guide catheter and guide wire as a single unit.There were no adverse patient effects and there was no reported 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 deflation issue was not confirmed.The reported 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 identified no other similar incidents and/or complaints from this lot.It was reported by the account that the contrast mix used for the procedure was 50ml contrast and 20ml saline.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global instructions for use (ifu) specifies that the contrast is 60% contrast medium diluted 1:1 with normal saline.Contrast that is more concentrated can lead to slower inflation and deflation times.In this case, it is likely that the concentrated contrast solution contributed to the reported deflation issue.Furthermore, it is likely that the reported difficulty removing the device resulted from the balloon experiencing deflation issues.Additionally, it was reported that the device was prepped inside the anatomy.It should be noted the coronary dilatation catheters (cdc), nc trek rx, global, costa rica, instruction for use (ifu) 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 unlikely that the ifu violation contributed to the reported difficulty thus.The investigation determined the reported deflation issues appears to be related to user error; however, the reported difficulty removing the device appears to be related to operational context.In this case, it is likely that the concentrated contrast solution contributed to the reported deflation issue.Furthermore, it is likely that the reported difficulty removing the device resulted from the balloon experiencing deflation issues.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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: 17128295
• Report Number: 2024168-2023-06262
• Device Sequence Number: 15064942
• Product Code: LOX
• UDI-Device Identifier: 08717648152122
• UDI-Public: 08717648152122
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2023

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: 09/30/2023
• Device Model Number: 1012454-20
• Device Catalogue Number: 1012454-20
• Device Lot Number: 01001G1
• 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: 05/23/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2020
• 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