MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER COOL-TIP; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	RFASW
Medical Device Problem Codes	Device Alarm System (1012); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/19/2024
Type of Reportable Event	Death
Event or Problem Description
According to the reporter, during a procedure, the generator alarms sounded and it did not reach the temperature.The procedure was aborted-patient under anesthesia and could not be performed because the patient was bleeding.Surgeon cauterize the bleeding.Patient was admitted to intensive care.
Additional Manufacturer Narrative
D10 concomitant products: cagen1 ablation generator x1 (sn:(b)(6)); cart1 ablation cart x1 (lot#unknown); capump1, capump1 ablation pump x1 (sn:(b)(6)); ca190rc1 ablation reusable cable x1 (sn:(b)(6)).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
New information has been received pertaining to the event.This event has been reassessed and the reportability has been determined to be a death.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during a procedure, the generator alarms sounded and it did not reach the temperature.The procedure was aborted-patient under anesthesia and could not be performed because the patient was bleeding.The surgeon cauterize the bleeding.The patient was admitted to intensive care.The patient has died.
Event or Problem Description
According to the reporter, during a procedure, the generator had general error and it did not reach the temperature.Customer restarted the generator then turned off and disconnected the generator and cart for 10 minutes as the manual indicates.Tried this 3 times, then used a different antenna and a new and cold bag of 1 liter of saline solution.As it didn't work again, tried doing the same steps and changed the outlet where it was connected.The procedure was aborted, patient was under anesthesia and procedure was not performed because the patient was bleeding.Surgeon used an electrocautery to cauterize the bleeding, it didn't stop.Surgeon had to maintain pressure with gauze, put several gauzes inside the patient and kept them inside for 2 days in order to stop the bleeding.Patient was admitted to intensive care.The patient had died and the cause was unknown.The last thing the doctor mentioned that the patient had pneumonia and was not waking up from anesthesia.
Additional Manufacturer Narrative
Additional information: b5, g3.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during a procedure, the generator flashes the general warning alert in red and it did not reach the temperature.Customer restarted the generator, then turned off and disconnected the generator and cart for 10 minutes as the manual indicates, tried this 3 times, then used a different antenna and a new and cold bag of 1 liter of saline solution, as it didn't work again, tried doing the same steps, verified proper connection of reusable cable to generator, ensured the cooling pump was on and changed the outlet were it was connected.The procedure was aborted-patient was under anesthesia.However, the antenna could not be removed because the patient was bleeding too much, surgeon used an electrocautery to cauterize the bleeding; it didn't stop, had to maintain pressure with gauze; put several gauzes inside the patient and kept them inside for 2 days in order to stop the bleeding.Surgeon decided to take the patient to another private hospital by ambulance to the intensive care unit.The patient left the hospital in a stable condition as indicated by the doctor but of course the case was delicate as bleeding was packaged.The patient has died and the cause was unknown.The last thing the doctor mentioned that the patient had pneumonia and was not waking up from anesthesia.
Additional Manufacturer Narrative
Correction: a2, b5 additional information: g3 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: COOL-TIP
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19342992
• Report Number: 1717344-2024-01160
• Device Sequence Number: 15239520
• Product Code: NEY
• UDI-Device Identifier: 10884521048720
• UDI-Public: 10884521048720
• Combination Product (Y/N): N
• Initial Reporter Country: GT
• PMA/510(K) Number: K133821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/25/2024

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 Model Number: RFASW
• Device Catalogue Number: RFASW
• Device Lot Number: 336091X
• 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: 04/19/2024
• Supplement Date Received by Manufacturer: 05/22/2024; 10/17/2024; 10/24/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 06/03/2024; 10/22/2024; 10/25/2024
• Date Device Manufactured: 03/19/2018
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Life Threatening; Other; Required Intervention; Death
• Patient Age: 66 YR
• Patient Sex: Male