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

Catalog Number	1012453-12
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	05/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.Production 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.It was reported by the account that the balloon was removed inflated.It should be noted the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu), states: withdraw the deflated dilatation catheter and guide wire from the guiding catheter through the hemostatic valve.In this case, it is likely that the ifu violation contributed to the reported difficulty removing the device.Possible factors that may contribute to difficulty deflating the balloon include, but are not limited to, deflation technique, tortuous anatomy, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.In this case, a conclusive cause for the reported deflation issue could not be determined since the device was not returned for analysis.Additionally, it is likely that the reported deflation issue contributed to the resistance met with the previously implanted stent during removal since the balloon would not fully deflate.Based on the reported information and results of the complaint investigation, there is no indication that the reported deflation issue or difficulty removing the device are related to a product quality issue with respect to the design, manufacture, or labeling of the device.H6 - medical device problem code 2017 clarifier: failure to follow steps / instructions.
Event or Problem Description
It was reported that the procedure was to treat a 95% stenosed lesion in the left anterior descending (lad) artery with calcification.For post dilatation, the 4x12mm nc trek balloon dilatation catheter (bdc) was uses and the balloon was inflated to 14 atmospheres (atm); however, the balloon became stuck with the previously implanted stent.Negative was held for 2 seconds and the balloon deflated 5%.The bdc had to be removed with the other devices being used in the procedure.There was no adverse patient effect reported and no clinically significant delay reported 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: 19524261
• Report Number: 2024168-2024-07042
• Device Sequence Number: 18277887
• Product Code: LOX
• UDI-Device Identifier: 08717648152061
• UDI-Public: (01)08717648152061(17)260930(10)31010G1
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2024

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: 09/30/2026
• Device Catalogue Number: 1012453-12
• Device Lot Number: 31010G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2023
• 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