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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FREUDENBERG MEDICAL STEERABLE INTRODUCER SHEATH 12F
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FREUDENBERG MEDICAL STEERABLE INTRODUCER SHEATH 12F Back to Search Results
Model Number SS120065
Device Problem Material Rupture (1546)
Patient Problem Ventricular Fibrillation (2130)
Event Date 12/02/2021
Event Type  Injury  
Event Description
Cryoablation balloon ruptured during use with steerable introducer sheath being used for gaining access to left atrium.Patient went into v-fib and required multiple shocks to stabilize.
 
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Brand Name
STEERABLE INTRODUCER SHEATH 12F
Type of Device
STEERABLE INTRODUCER SHEATH
Manufacturer (Section D)
FREUDENBERG MEDICAL
2301 centennial blvd
jeffersonville IN 47130 8975
Manufacturer (Section G)
FREUDENBERG MEDICAL
2301 centennial blvd
jeffersonville IN 47130 8975
Manufacturer Contact
scott hanson
2301 centennial blvd
jeffersonville, IN 47130-8975
8122802322
MDR Report Key13772878
MDR Text Key287340199
Report Number1000121130-2022-00001
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192422
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberSS120065
Device Catalogue NumberPN1008533-004
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
MEDTRONIC ARCTICFRONT; MEDTRONIC CRYO CONSOLE
Patient Outcome(s) Other; Required Intervention;
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