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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAMIC XT; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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BOSTON SCIENTIFIC CORPORATION DYNAMIC XT; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Model Number 86708
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Patient Involvement (2645)
Event Date 11/09/2018
Event Type  malfunction  
Event Description
It was reported that the inner package was compromised.Prior to a procedure, when the dynamic xt catheter was taken out of outer package, the inner package was found to be compromised.There was no patient involvement and the device was never used.
 
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Brand Name
DYNAMIC XT
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
302 parkway
global park, la aurora,
heredia
CS  
Manufacturer Contact
timothy degroot
4100 hamline avenue north
dc a330,
saint paul, MN 55112
6515826168
MDR Report Key8153044
MDR Text Key130048814
Report Number2134265-2018-63868
Device Sequence Number1
Product Code DRF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K921872
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/11/2018
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
Device Operator Health Professional
Device Model Number86708
Device Catalogue Number86708
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/16/2018
Initial Date FDA Received12/11/2018
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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