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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
Lot Number 0028359219
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/20/2022
Event Type  malfunction  
Event Description
It was reported that when the device was opened, there was a black stain on the packaging paper that contained the polarsheath.The sterile seal was not damaged or compromised.But the sheath was suspected to be dirty, and was replaced.The procedure was completed successfully, and no patient complications were reported.
 
Event Description
It was reported that when the device was opened, there was a black stain on the packaging paper that contained the polarsheath.The sterile seal was not damaged or compromised.But the sheath was suspected to be dirty, and was replaced.The procedure was completed successfully, and no patient complications were reported.
 
Manufacturer Narrative
The device was received at boston scientific for analysis.The original packaging was not received, and no black stain was observed on the returned device.The reported event was not confirmed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
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Brand Name
POLARSHEATH
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 Key15009022
MDR Text Key295874868
Report Number2134265-2022-07888
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/20/2022
Device Lot Number0028359219
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/09/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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