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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 0028735784
Device Problem Mechanics Altered (2984)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/19/2022
Event Type  malfunction  
Event Description
During a cryoablation procedure, a polarsheath was selected for use.There was normal preparation of the polarsheath.An exchange over the wire was done and the sheath was placed in the left atrium (la).After insertion of the polarx balloon the sheath was manipulated towards the left superior pulmonary vein (lspv).The physician noticed that when rotating the knob the curve deflection came back when the knob was released.The case was continued but it was difficult to use the sheath.Physician had to hold the rotation knob fixated to keep the curve on the polarsheath.The right inferior pulmonary vein (ripv) was the last vein to isolate.The physician lost access to the left atrium when trying to cannulate this vein.The procedure was then aborted.No patient complications were reported.The device has been returned.
 
Event Description
During a cryoablation procedure, a polarsheath was selected for use.There was normal preparation of the polarsheath.An exchange over the wire was done and the sheath was placed in the left atrium (la).After insertion of the polarx balloon the sheath was manipulated towards the left superior pulmonary vein (lspv).The physician noticed that when rotating the knob the curve deflection came back when the knob was released.The case was continued but it was difficult to use the sheath.Physician had to hold the rotation knob fixated to keep the curve on the polarsheath.The right inferior pulmonary vein (ripv) was the last vein to isolate.The physician lost access to the left atrium when trying to cannulate this vein.The procedure was then aborted.No patient complications were reported.The device has been returned.
 
Manufacturer Narrative
The polarsheath was returned to boston scientific for analysis.Mechanical testing revealed the sheath steering would not hold deflection as the steering knob was set into action and left without contact.No external factors effecting the steering were identified that lead to the complaint allegation both visually and functionally.Dissection of the proximal handle was performed, and pdms (silicone oil) was visible on regions critical to the affection of deflection.The presence of this oil on the unintended regions causes less friction while rotating the steering knob which reduces the ability of the steering knob to maintain deflection through resistance.Oil is originally injected into the proximal hemostatic valve as per manufacturing process, and migrating oil is under investigation for possible root cause.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
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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
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key15428763
MDR Text Key305341950
Report Number2124215-2022-36133
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeBE
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 10/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/05/2022
Device Lot Number0028735784
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/24/2022
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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