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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR COLD; SNARE, FLEXIBLE

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BOSTON SCIENTIFIC CORPORATION CAPTIVATOR COLD; SNARE, FLEXIBLE Back to Search Results
Model Number M00561100
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/27/2021
Event Type  malfunction  
Event Description
When attempting to use snare it wouldn't open, then it snapped.New snare obtained.
 
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Brand Name
CAPTIVATOR COLD
Type of Device
SNARE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key12473790
MDR Text Key271457977
Report Number12473790
Device Sequence Number1
Product Code FDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 09/10/2021
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 NumberM00561100
Device Lot Number27598693
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/03/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/10/2021
Event Location Ambulatory Surgical Facility
Date Report to Manufacturer09/15/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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