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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; CARDIAC ABLATION PERCUTANEOUS CATHETER
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BOSTON SCIENTIFIC CORPORATION; CARDIAC ABLATION PERCUTANEOUS CATHETER Back to Search Results
Device Problem Noise, Audible (3273)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2023
Event Type  malfunction  
Event Description
It was reported that during use of a boston scientific electrophysiology radio frequency ablation catheter to treat paroxysmic atrial fibrillation (a fib) a steam pop was observed.No information regarding the completion status of the procedure, the patient's outcome, innervations required for the steam pop, the model of the catheter used, the return availability of the device, or the name of the initial reporter were provided.
 
Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
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Type of Device
CARDIAC ABLATION PERCUTANEOUS CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer Contact
timothy degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key18051760
MDR Text Key327710857
Report Number2124215-2023-60375
Device Sequence Number1
Product Code LPB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received10/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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