MAUDE Adverse Event Report: BOLDER SURGICAL COOLSEAL¿ GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	CSL-200-50
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/18/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.The device was returned for inspection which found no concerns and met the manufacturer´s specifications.
Event or Problem Description
It was reported that during a coolseal trinity procedure on (b)(6) 2024, a coolseal trinity 30cm and coolseal generator were used during a thoracoscopic procedure on a child (6 years old, female), dissecting and sealing vessels.During the procedure it was identified that the patient was bleeding from a previously dissected and sealed branch of the pulmonary artery, and there were concerns of a potential seal failure.The patient suffered significant bleeding which could not be stopped, resulting in patient death.On a follow up email it was determined that the bleeding started 3 hours after the surgery began, major bleeding was encountered from a corner of a previously sealed and divided basal arterial branch.The procedure was a video assisted thoracoscopic lobectomy surgery.No pre-existent conditions were reported.Multiple steps were taken after the bleeding was observed to treat it, compression, tranexamic acid and blood transfusion.No other information was received.

• Brand Name: COOLSEAL¿ GENERATOR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOLDER SURGICAL; 331 south 104 street; suite 200; louisville CO 80027
• Manufacturer (Section G): BOLDER SURGICAL; 331 south 104 street; suite 200; louisville CO 80027
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102 ; CR 20102
• MDR Report Key: 21886897
• Report Number: 3010377594-2025-00006
• Device Sequence Number: 3443078
• Product Code: GEI
• UDI-Device Identifier: 00850346007023
• UDI-Public: (01)00850346007023(11)210420
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K211579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: CSL-200-50
• Device Catalogue Number: CSL-200-50
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Death
• Patient Sex: Unknown