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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENTINEL; TEMPORARY CATHETER, EMBOLIC PROTECTION, TRANSCATHETER INTRACARDIAC PROCEDURES
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BOSTON SCIENTIFIC CORPORATION SENTINEL; TEMPORARY CATHETER, EMBOLIC PROTECTION, TRANSCATHETER INTRACARDIAC PROCEDURES Back to Search Results
Model Number CMS15-10C-US
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/19/2020
Event Type  Injury  
Event Description
During tavr (trans aortic valve replacement) procedure, sentinel device placed through 6fr slender sheath in right radial artery.At the end of the case, the sentinel device was removed.When sheath subsequently was to be removed, it was noted that sheath was "broken".Inspection of the sentinel device showed the sheath sheared off and still attached to the device at the level of the first basket, which was not deployed.Vascular surgery called and examined patient.No intervention was required, and patient was transferred to recovery unit.
 
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Brand Name
SENTINEL
Type of Device
TEMPORARY CATHETER, EMBOLIC PROTECTION, TRANSCATHETER INTRACARDIAC PROCEDURES
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key10739758
MDR Text Key213234107
Report Number10739758
Device Sequence Number1
Product Code PUM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/21/2020
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 NumberCMS15-10C-US
Device Catalogue NumberCMS15-10C-US
Device Lot Number25997745
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/21/2020
Event Location Hospital
Date Report to Manufacturer10/27/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age33215 DA
Patient Weight69
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