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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC RHYTHMIA MAPPING SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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BOSTON SCIENTIFIC RHYTHMIA MAPPING SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Patient Problems Perforation (2001); Pericardial Effusion (3271)
Event Type  Injury  
Event Description
Following a successful cryo ablation procedure, a post-activation mapping procedure was performed with boston scientific¿s orion mapping catheter and rhythmia mapping system.The orion mapping catheter was inserted into the left appendage and subsequently the appendage was perforated.Following the post activation mapping procedure, a large effusion was seen forming under intracardiac echocardiography (ice).The patient underwent a pericardial tap, emergency surgery, and extended or prolonged hospitalization.This report reflects information received by fda in the form of a notification per 803.22 (b) (2).Ref report: mw5146773.
 
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Brand Name
RHYTHMIA MAPPING SYSTEM
Type of Device
COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
BOSTON SCIENTIFIC
MDR Report Key17911625
MDR Text Key325577618
Report NumberMW5146774
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 09/14/2023
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
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/10/2023
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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