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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 0029112334
Device Problems Leak/Splash (1354); Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/27/2022
Event Type  malfunction  
Event Description
It was reported that during a cryo-ablation procedure to treat atrial fibrillation (a fib) using a polarsheath, it was observed that the sheath was leaking with air bubbles.It appeared that the leak was coming from the hemostatic valve.They exchanged the sheath and the issue was resolved.The procedure was then completed with no patient complications.The sheath is expected to be returned for analysis.This product is part of the 92688876-fa advisory population for the polarsheath steerable sheath.
 
Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
T was reported that during a cryo-ablation procedure to treat atrial fibrillation (a fib) using a polarsheath, it was observed that the sheath was leaking with air bubbles.It appeared that the leak was coming from the hemostatic valve.They exchanged the sheath and the issue was resolved.The procedure was then completed with no patient complications.The sheath has been received at boston scientific's post market laboratory for analysis.This product is part of the 92688876-fa advisory population for the polarsheath steerable sheath.
 
Manufacturer Narrative
Upon receipt at boston scientific's post market laboratory the sheath was first visually inspected, and no visual abnormalities were found.Next, they functionally tested the sheath by replicating aspiration and the sheath was within specification and showed no air bubbles for each variation of the test.Then, they tested the integrity of the hemostatic valve and found the sheath was within specification for maintaining internal pressure and no leaks were observed.Based on all the available evidence the conclusion is that no problem was detected with the returned device; a the reported allegation could not be replicated, and no other issues were found with the device.
 
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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
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key15539230
MDR Text Key305544272
Report Number2124215-2022-39568
Device Sequence Number1
Product Code DRF
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
Remedial Action Notification
Type of Report Initial,Followup
Report Date 12/21/2022
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 Expiration Date02/03/2023
Device Lot Number0029112334
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/28/2022
Initial Date FDA Received10/04/2022
Supplement Dates Manufacturer Received12/20/2022
Supplement Dates FDA Received12/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/25/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number92688876-FA
Patient Sequence Number1
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