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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARADRIVE STEERABLE SHEATH CLEAR; VASCULAR GUIDE-CATHETER, SINGLE-USE
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BOSTON SCIENTIFIC CORPORATION FARADRIVE STEERABLE SHEATH CLEAR; VASCULAR GUIDE-CATHETER, SINGLE-USE Back to Search Results
Lot Number CL12427
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/27/2024
Event Type  malfunction  
Event Description
It was reported that during preparation for an irreversible electroporation ablation procedure using a faradrive sheath foreign material was flushed out of the device.During preparation the sheath was flushed, outside of the patient, and the user reported that a black particle came out of the sheath.They exchanged the sheath, and the issue was resolved.The procedure was then completed with no patient complications.The sheath has been received and is awaiting analysis.
 
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Brand Name
FARADRIVE STEERABLE SHEATH CLEAR
Type of Device
VASCULAR GUIDE-CATHETER, SINGLE-USE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
CENTERPOINT SYSTEMS
3338 parkway blvd
west valley city UT 84119
Manufacturer Contact
timothy degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key19140315
MDR Text Key340646300
Report Number2124215-2024-23541
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/18/2024
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 Lot NumberCL12427
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/27/2024
Initial Date FDA Received04/18/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/07/2024
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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