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

Model Number	CSL-TR105-30
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
H6: appropriate term/code not available: suggested code : electrosurgical cutter and coagulator.Lot number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.
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¿ TRINITY
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOLDER SURGICAL; 331 south 104 street; louisville CO 80027
• Manufacturer (Section G): BOLDER SURGICAL; 331 south 104 street; louisville CO 80027
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102 ; CR 20102
• MDR Report Key: 21886742
• Report Number: 3010377594-2025-00005
• Device Sequence Number: 15550459
• Product Code: GEI
• UDI-Device Identifier: 00850346007030
• UDI-Public: 00850346007030
• 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-TR105-30
• Device Catalogue Number: CSL-TR105-30
• Was Device Available for Evaluation?: No
• 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): No
• 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: Required Intervention; Death; Hospitalization
• Patient Sex: Unknown