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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The additional device referenced in b5 is filed under separate medwatch report number.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 of the reported lot did not indicate a lot specific quality issue.Possible factors that may contribute to difficulty deflating the balloon include, but are not limited to, deflation technique, tortuous anatomy, loose connection with the in-deflator, 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 anatomy 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.
Event or Problem Description
It was reported the procedure was to treat a heavily calcified and mildly tortuous lesion in the left main.He 4.0x15mm nc trek balloon dilatation catheter (bdc) was advanced to the target lesion and inflated twice to 14 atmospheres.During deflation contrast was noted still in the balloon.Deflation was attempted again and the bdc was removed with resistance noted.It was noted the balloon was not completely deflated.After stenting post dilatation was performed with the 4.0x12mm nc trek however when deflating the balloon, contrast was seen inside balloon.Several attempts were made to deflate the balloon and resistance was met during retraction.The bdc and guiding catheter were removed together as a unit.There was no clinically significant delay in the procedure and no adverse patient effects.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: 19518831
• Report Number: 2024168-2024-06965
• Device Sequence Number: 20353753
• Product Code: LOX
• UDI-Device Identifier: 08717648152061
• UDI-Public: (01)08717648152061(17)251031(10)21110G1
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: 10/31/2025
• Device Catalogue Number: 1012453-12
• Device Lot Number: 21110G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2022
• 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