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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH

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BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH Back to Search Results
Model Number M004CRBS3050
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/11/2022
Event Type  malfunction  
Event Description
It was reported that prior to an pulmonary vein isolation (pvi) procedure, a polarsheath steerable sheath was selected for use. When the physician took the sheath and dilator out of the package, he noted that the end of the dilator was not circular and was an excess of material. The excess of material was removed with a scalpel. The procedure was completed with this device without any patient complications. The device is not expected to be returned since it was discarded.
 
Manufacturer Narrative
The device will not be returned for analysis since it was discarded at the facility. If there is any further relevant information a supplemental medwatch will be filed.
 
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Brand NamePOLARSHEATH
Manufacturer (Section D)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
302 parkway
global park, la aurora
heredia
CS
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 Key14470323
MDR Text Key296151087
Report Number2134265-2022-05828
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/04/2022
Device Model NumberM004CRBS3050
Device Lot Number0028077611
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/23/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown

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