MAUDE Adverse Event Report: MEDTRONIC, INC. CRYOFLEX SURGICAL ABLATION PROBE; SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE

Model Number 60SF2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Infarction, Cerebral (1771); Inflammation (1932); Sepsis (2067); Thrombus (2101); Cardiac Tamponade (2226); Low Cardiac Output (2501); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

Event date was not made available through this survey.Hospital details and healthcare professionals information not made available through this survey.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information through a post market clinical follow-up (pmcf) survey that following use of the cryocath probes at an unspecified time the patients experienced the following events, bleeding, reoperation, cardiac tamponade, thrombus formation, low cardiac output, stroke, sepsis, mediastinitis, pericarditis and conduction disturbances.No further information is available.

• Brand Name: CRYOFLEX SURGICAL ABLATION PROBE
• Type of Device: SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8154407
• MDR Text Key: 130020957
• Report Number: 3008592544-2018-00059
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 60SF2
• Device Catalogue Number: 60SF2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2018
• 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 Outcome(s): Hospitalization