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

Model Number	1012447-15
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified, mildly tortuous, 90% stenosed lesion in the right coronary artery (rca).A 2.50x15mm nc trek balloon dilatation catheter (bdc) was advanced to the target lesion and used for dilatation without issue.Upon attempted removal of the device, the balloon was being pulled back into the catheter, but met resistance with the calcification in the rca.The physician pulled the bdc to pull it back into the catheter, resistance was then met with the guide catheter, and the balloon separated from the hypotube.The separated balloon was removed by endarterectomy, and the procedure was completed via coronary artery bypass surgery (cabg).There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Na.
Additional Manufacturer Narrative
The device was not returned for evaluation.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.The investigation was unable to determine a conclusive cause for the reported difficulty removing the device from the guiding catheter; however, the reported balloon rupture, difficulty removing the device from the anatomy, balloon separation, surgical intervention and hospitalization appears to be related to circumstances of the procedure.It was reported that the bdc interacted with the heavily calcified and mildly tortuous anatomy resulting in the reported balloon rupture and subsequently the ruptured balloon material became caught on the calcified anatomy resulting in the reported difficulty removing the device.Additionally, possible factors that can contribute to difficult to remove/resistance with the guiding catheter post-inflation include, but are not limited to, loose balloon folds, guiding catheter lumen obstructions, kinks, bends or procedural technique.Furthermore, it is likely that upon manipulation of the device during removal, as difficulty was encountered with the guiding catheter, the balloon ultimately separated and had to be removed by endarterectomy, and the procedure was completed via coronary artery bypass surgery (cabg).There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.It was reported by the account that the balloon dilatation catheter (bdc) interacted with the heavily calcified and mildly tortuous anatomy resulting in the reported balloon rupture and subsequently the ruptured balloon material became caught on the calcified anatomy resulting in the reported difficulty removing the device.Per the instructions-for-use (ifu), within the warnings section the following is listed: treatment of moderately or heavily calcified lesions is considered to be moderate risk, with increase in the risk of acute closure, vessel trauma, balloon burst, balloon entrapment, and associated complications.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.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded that based on the addendum information provided, the user has confirmed that the balloon rupture was directly related to its interaction with the heavy calcium burden at the deployment site, as previously presumed.The hypotube detachment was confirmed to have occurred when the user met resistance with the guide catheter and excessive force was applied.This additional information confirms the prior conclusion that the user did not follow the instructions-for-use (ifu) warnings as noted previously.
Event or Problem Description
Subsequent to the initially filed report, additional information was received: the 2.50x15mm nc trek balloon dilatation catheter (bdc) was advanced to the target lesion and used for dilatation without issue.Upon attempted removal of the device, the balloon met resistance with the calcification in the rca.When the bdc was pulled back into the catheter, resistance was met with the guide catheter, and the balloon separated from the hypotube.The separated balloon was removed by endarterectomy, and the procedure was completed via coronary artery bypass surgery (cabg).There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.

• 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: 16903935
• Report Number: 2024168-2023-04998
• Device Sequence Number: 5561910
• Product Code: LOX
• UDI-Device Identifier: 08717648151767
• UDI-Public: 08717648151767
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 07/06/2023

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: 08/31/2025
• Device Model Number: 1012447-15
• Device Catalogue Number: 1012447-15
• Device Lot Number: 20906G2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/17/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female