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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, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Lot Number 0029104697
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/26/2022
Event Type  malfunction  
Event Description
It was reported that when a polarsheath steerable sheath was received at the hospital the package was found damaged on outer shipping box.Device shipping boxes had been crushed and the seal on the device boxes was detached.It was unknown if the sterile packaging was compromised.The device was not used and is expected to be returned.
 
Event Description
It was reported that when a polarsheath steerable sheath was received at the hospital the package was found damaged on outer shipping box.Device shipping boxes had been crushed and the seal on the device boxes was detached.It was unknown if the sterile packaging was compromised.The device was not used and is expected to be returned.
 
Manufacturer Narrative
The device was returned to boston scientific for analysis.Per visual inspection box was damaged on arrival.
 
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Brand Name
POLARSHEATH
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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 Key14859102
MDR Text Key302596325
Report Number2134265-2022-07524
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/02/2023
Device Lot Number0029104697
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/24/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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