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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION; PROBE, RADIOFREQUENCY LESION
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BOSTON SCIENTIFIC NEUROMODULATION; PROBE, RADIOFREQUENCY LESION Back to Search Results
Model Number TCN-10
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/25/2019
Event Type  malfunction  
Event Description
A report was received that during the cleaning of the electrode there was blood found to be seeping into the hub of the probe.The device is expected for analysis but has not been received despite good faith efforts so far.
 
Event Description
A report was received that during the cleaning of the electrode there was blood found to be seeping into the hub of the probe.The device is expected for analysis but has not been received despite good faith efforts so far.
 
Manufacturer Narrative
The electrode tcn-10 was returned to bsn.The complaint of "blood was coming out of the hub" was confirmed due to blood was coming out of the hub.The probable cause selected is "unintended use error caused or contributed to event".The complaint mentions that the probes were cleaned with peroxide, which does not follow our ifu.Additionally, it is during the cleaning procedure that a tech would likely encounter blood on the device regardless of seeping, and cleaning with the peroxide could bubble from interacting with any blood.The customer is not supposed to use peroxide when cleaning the electrode.Per our ifus the probes should be cleaned first in an enzymatic cleaner bath, and then autoclaved.
 
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Brand Name
NA
Type of Device
PROBE, RADIOFREQUENCY LESION
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key8799408
MDR Text Key151336925
Report Number3006630150-2019-03627
Device Sequence Number1
Product Code GXI
Combination Product (y/n)N
PMA/PMN Number
K050084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 10/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberTCN-10
Device Catalogue NumberTCN-10
Device Lot Number23049693
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2019
Date Manufacturer Received10/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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