MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC EMPRINT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	CA190RC1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Retroperitoneal Hemorrhage (4483)
Date of Event	10/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant prod: ca190rc1 (ca190rc1 ablation reusable cable x1, lot number: ec21422342); ca20l2 (ca20l2 20 cm rein percutaneous antenna x1, lot number: s2eg002x); ca20l2 (ca20l2 20 cm rein percutaneous antenna x1, lot number: s2eg002x).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 or Problem Description
According to the reporter, during ablation in tumor lesion located on superior pole of the left kidney, the antenna had been difficult to fix to the reusable cable, the plastic rotative fixation ring did not work as it should be.The antenna has been detected for few seconds, then not recognize in result of the lack of fixation of the reusable cable.Due to first antenna's malfunction caused by the reusable cable, another antenna has been used with another reusable cable (fully functional).But due to fragile vascular state of the patient and his tumor, the second antenna caused important retro-peritoneal bleeding (resolved the same day later with no complication), that lead to the stop of the procedure while the patient is under anesthesia.The stopped from itself, no embolization needed.The procedure was re scheduled for the next day.Two antennas has been used with no results because of malfunction of reusable cable.

• Brand Name: EMPRINT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer (Section G): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15675751
• Report Number: 3004962788-2022-00088
• Device Sequence Number: 12355441
• Product Code: GEI
• UDI-Device Identifier: 10884521190764
• UDI-Public: 10884521190764
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2022

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: CA190RC1
• Device Catalogue Number: CA190RC1
• Device Lot Number: EC21452466
• 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: 10/10/2022
• Initial Report FDA Received Date: 10/26/2022
• Date Device Manufactured: 11/09/2021
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male