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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD INTRA CARDIAC ACCESSS CATHETER; ACCESSORY
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ST. JUDE MEDICAL, INC., CRMD INTRA CARDIAC ACCESSS CATHETER; ACCESSORY Back to Search Results
Model Number 410212
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Complete Heart Block (2627)
Event Date 02/27/2015
Event Type  Injury  
Event Description
It was reported that during the implant procedure, the outer guide catheter came into contact with the atrioventricular node; the patient experienced third degree heart block and became asystolic.An emergency resuscitation was performed.A temporary pacing lead was placed and the procedure was aborted.The patient was fine post procedure.
 
Manufacturer Narrative
All information provided by manufacturer, no medwatch form was received.(b)(4).
 
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Brand Name
INTRA CARDIAC ACCESSS CATHETER
Type of Device
ACCESSORY
Manufacturer (Section D)
ST. JUDE MEDICAL, INC., CRMD
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC., CRMD
15900 valley view court
sylmar CA 91342
Manufacturer Contact
jennie hamel
15900 valley view court
sylmar, CA 91342
8184933462
MDR Report Key4752761
MDR Text Key18039243
Report Number2017865-2015-04476
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number410212
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/20/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/27/2015
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 Number1
Patient Outcome(s) Required Intervention;
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