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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; CATHETER, STEERABLE
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BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH; CATHETER, STEERABLE Back to Search Results
Lot Number 0030835647
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/23/2023
Event Type  malfunction  
Event Description
During preparation of a pulmonary vein isolation a polarsheath was selected for use.The sheath experienced a break/detachment from an area that would enter the patient.The procedure was completed with a non-bsc product.No patient complications were reported.
 
Manufacturer Narrative
Initial reporter phone: (b)(6).It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
 
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Brand Name
POLARSHEATH
Type of Device
CATHETER, STEERABLE
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 degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key17269860
MDR Text Key318579323
Report Number2124215-2023-34620
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 07/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/22/2023
Device Lot Number0030835647
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/23/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/11/2023
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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