MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER FORCFX-8; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number FORCEFX

Device Problems Arcing (2583); Appropriate Term/Code Not Available (3191)

Patient Problems Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)

Event Date 09/07/2023

Event Type  malfunction  

Event Description

According to reporter, during the attempted implant of this transcatheter bioprosthetic valve via left femoral access, the delivery catheter system (dcs) was unable to advance due to angulation or kinking in the aorta.The system was withdrawn from the patient, and a decision was made to attempt implant using a surgical left subclavian approach.The incision was made using an electric scalpel.Subsequently, there was a spark that caused a skin burn on the lateral side of the left hemithorax and the inner side of the left arm.The burn was treated using saline solution and silver sulfadiazine.The procedure was subsequently aborted.No additional adverse patient effects were reported.The wounds were healed with antibiotic therapy.Patient was discharged from the hospital.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to reporter, during the attempted implant of this transcatheter bioprosthetic valve via left femoral access, the delivery catheter system (dcs) was unable to advance due to angulation or kinking in the aorta.The system was withdrawn from the patient, and a decision was made to attempt implant using a surgical left subclavian approach.The incision was made using an electric scalpel.Subsequently, there was a spark that caused a 2nd degree skin burn on the lateral side of the left hemithorax and the inner side of the left arm.The burn was treated using saline solution and silver sulfadiazine.The procedure was subsequently aborted.No additional adverse patient effects were reported.The wounds were healed with antibiotic therapy.Patient was discharged from the hospital.

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 malfunction.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FORCFX-8
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• 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: 17964964
• MDR Text Key: 326032591
• Report Number: 1717344-2023-01293
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884524002613
• UDI-Public: 10884524002613
• Combination Product (y/n): N
• Reporter Country Code: UY
• PMA/PMN Number: K944602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2023

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
• Device Operator: Health Professional
• Device Model Number: FORCEFX
• Device Catalogue Number: FORCEFX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/19/2023
• Supplement Dates Manufacturer Received: 10/19/2023; 11/07/2023
• Supplement Dates FDA Received: 11/09/2023; 12/04/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 95 KG