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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 86706
Device Problem Material Perforation (2205)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2023
Event Type  malfunction  
Event Description
It was reported that during preparation for a procedure using a dynamic xt catheter the shaft of the sheath was broken.They exchanged the catheter, and the issue was resolved.The procedure was then completed with no patient complications.The catheter is expected to be returned for analysis.
 
Manufacturer Narrative
Upon receipt at boston scientific's post market laboratory the catheter was visually inspected, and it was found the plunger that controls the steering of the catheter had separated from the rest of the handle.The reported allegation of irrigation failure was confirmed, however, the root cause for the break could not be determined from the information provided from the site or from examining the damaged device.
 
Event Description
It was reported that during preparation for a procedure using a dynamic xt catheter the shaft of the sheath was broken.They exchanged the catheter, and the issue was resolved.The procedure was then completed with no patient complications.The catheter has been received for analysis.
 
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Brand Name
DYNAMIC XT
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
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 Key17270174
MDR Text Key318565665
Report Number2124215-2023-34168
Device Sequence Number1
Product Code DRF
UDI-Device Identifier08714729877622
UDI-Public08714729877622
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K921872
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 09/08/2023
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
Device Operator Health Professional
Device Model Number86706
Device Catalogue Number86706
Device Lot Number0030486967
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/09/2023
Initial Date FDA Received07/06/2023
Supplement Dates Manufacturer Received08/24/2023
Supplement Dates FDA Received09/08/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/05/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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