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

Model Number ACT2030

Device Problem Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during ablation procedure, frequency pin operation is unstable (power fluctuated up and down).They used another like device and it worked fine.There was no patient injury.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted a large bend to the needle or electrode of the device.A circulation leak test was preformed and water passed through the dev ice's tubing without issue.The tubing was crimped to create back pressure, however no leaks were observed.No nicks were seen on the tubing and cable.The device passed a hipot test.The device was able to accurately detect temperature.An ablation test was preformed on porcine kidney.The kidney was dissected and the device had ablated the area with acceptable results.It was reported that the temperature of the device was unstable or fluctuating.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: the unit was mishandled or dropped.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: verify that all components are undamaged prior to use.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 the reporter, during ablation procedure, the frequency pin operation is unstable (power fluctuated up and down).The needle sometimes did not work during use, the temperature in the working area was sometimes normal, and sometimes it could not go up.They used another like device and it worked fine.There was no patient injury.

• Brand Name: COOL-TIP
• 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: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 13359068
• MDR Text Key: 284467990
• Report Number: 1717344-2022-00093
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884524001227
• UDI-Public: 10884524001227
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K973297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2023
• Device Model Number: ACT2030
• Device Catalogue Number: ACT2030
• Device Lot Number: 02470098X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 01/26/2022
• Supplement Dates Manufacturer Received: 02/14/2022
• Supplement Dates FDA Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male