MAUDE Adverse Event Report: ABBOTT VASCULAR INC. NC TREK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	1012455-15
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that the procedure was performed to treat a moderately calcified and heavily tortuous lesion in the mid left main coronary artery.The 5.00 x 15mm nc trek rx balloon dilatation catheter (bdc) was used to dilate the lesion; however, after removal it was noted that the balloon was separated in the anatomy.Several attempts were made to retrieve the detached balloon however were unsuccessful.The patient was transported to another hospital for additional treatment and the separated balloon was surgically removed on (b)(6) 2024.The patient died on (b)(6) 2024.Per the physician the death was related to the surgical removal of the separated device.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.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the production records and the corrective and preventive actions (capa) database was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The reported patient effect of death is listed in the nc trek instructions for use as a known patient effect of coronary stenting procedures.A medical review of the reported information was performed and the reviewer concluded the following: this case was to treat a lesion in the mid-left main (lm) artery that was moderately calcified and very tortuous.A 5 x 15 nc trek rx bdc was used to dilate the lm.Upon its removal, it was noted that the balloon was detached from the bdc and retained in the lm.It was reported that there was no resistance felt during the withdrawal.However, it was not reported if there were any issues, such as kinks, noticed with the balloon prior to insertion and/or advancing the balloon catheter, nor any issues with the balloon deflation or if any force was used during the removal.After several unsuccessful attempts to remove the retained balloon, the patient was transferred to another facility, where the balloon was surgically removed the following day.However, the patient expired three days later.It was reported that the physician stated that the patient¿s death was related to the surgical removal of the retained balloon.Due to the limited information and lack of cine images to review, it can not be definitively stated that the 5 x 15 nc trek rx bdc was the direct cause of the patient¿s death.However, the nc trek rx may have contributed to this patient¿s death, in addition to the air ambulance transfer to another country and surgical intervention to remove the retained balloon.The investigation was unable to determine a conclusive cause for the reported material separation or patient effect; however, the subsequent treatment appear to be related to the operational context of the procedure.It was reported that the balloon dilatation catheter (bdc) was observed to be separated after removal from the anatomy.Factors that may contribute to material separation during use include, but are not limited to, tensile strength, excessive force applied to device, interaction with accessory devices, and/or interaction with challenging anatomy.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported material separation.Additionally, it was reported that the separated portion of the bdc was attempted to be removed via a surgical procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Corrections: d9, h3 - device returning status updated from yes to no.E1 - physician's first name updated from (b)(6).

• Brand Name: NC TREK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 19798575
• Report Number: 2024168-2024-08625
• Device Sequence Number: 20714194
• Product Code: LOX
• UDI-Device Identifier: 08717648152153
• UDI-Public: (01)08717648152153(17)250731(10)20823G1
• Combination Product (Y/N): N
• PMA/510(K) Number: K110134
• 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): 09/27/2024

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: 07/31/2025
• Device Model Number: 1012455-15
• Device Catalogue Number: 1012455-15
• Device Lot Number: 20823G1
• 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: 07/04/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2022
• 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: Death
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Hispanic
• Patient Race: White