MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH; CATHETER, STEERABLE

Model Number 4FC12

Device Problem Material Twisted/Bent (2981)

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

Event Date 04/28/2023

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: universal cryoconsole, product id afapro28; product type: cath afapro28 afa pro 28; product id afapro28; product type: cath afapro28 afa pro 28, product id 2035u; product type: cable 2035u electrical umbilical; product id 2035u; product type: cable 2035u electrical umbilical.Product event summary: the 4fc12 sheath with lot 0011563071 was returned and analyzed.Visual inspection was performed, and a kink/twist was observed on the shaft.Visual inspection of the shaft area was performed and identified a shaft kink/twist at approximately 4.17 and 25.5 inches from the tip.Visual inspection of the handle area was performed, and no anomalies were identified.The handle had no cosmetic issues, and the side tube is connected properly to the handle.Visual inspection of the dilator was performed.No anomalies were identified, and the shaft, tip, and the length are according to specifications.In conclusion, the sheath failed the returned product inspection due to a shaft kink/twist.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.

Event Description

It was reported that during a cryo ablation procedure, the temperature was fluctuating unexpectedly and the system check was unable to be initiated.The electrical umbilical cable, auto connection box, and balloon catheter were replaced without resolution.The system was rebooted without resolution.The case was completed with another manufacturer's cryo ablation system.The temperature was later calibrated and the patient board was replaced which resolved the issues.No patient complications have been reported as a result of this event.

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17312589
• MDR Text Key: 319772343
• Report Number: 3002648230-2023-00347
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/12/2023

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 Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0011563071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2023
• Initial Date Manufacturer Received: 06/16/2023
• Initial Date FDA Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: PRODUCT ID 106A2-K, PRODUCT TYPE: CONSOLE 106A2-K