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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 0031909617
Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978); Mechanics Altered (2984)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2023
Event Type  malfunction  
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
It was reported that prior to a procedure to treat atrial fibrillation a polarsheath was selected for use.The locking mechanism on the sheath handle was broken and the curve of the sheath loosened when it was rotated.Additionally, a very small piece of plastic came out when the sheath was flushed.That piece of plastic did not appear to be related to the handle failure.The sheath was replaced and the procedure was completed.No patient complications were reported.The device is expected to be returned for analysis.
 
Event Description
It was reported that prior to a procedure to treat atrial fibrillation a polarsheath was selected for use.The locking mechanism on the sheath handle was broken and the curve of the sheath loosened when it was rotated.Additionally, a very small piece of plastic came out when the sheath was flushed.That piece of plastic did not appear to be related to the handle failure.The sheath was replaced and the procedure was completed.No patient complications were reported.The device was returned for analysis.
 
Manufacturer Narrative
The polarsheath was returned to boston scientific for analysis.Upon receipt at the post market quality assurance laboratory the sheath underwent visual inspection, mechanical testing, and microscope inspection.The polarsheath was visually inspected for any damage or defects that would have led to the unable to hold/maintain deflection issue seen in the field.The inspection of critical regions related to deflection were inspected and found to have no issues.The 3-way stop cock was returned attached to device.Nothing about the device was out of the ordinary that would account for the complaint of "a very small piece of plastic came out when the sheath was flushed." the polarsheath was then mechanically tested in attempt to recreate the unable to hold/maintain deflection issue.The polarsheath steering was set into action rotating the knob a full rotation, followed by a full two rotations.The knob was released after the rotation to observe if deflection was held.The steering knob rotated back without contact for both one and two full rotations.The polasheath handle was then dissected to observe the steering components and critical regions to maintaining deflection.Silicone oil was observed inside the handle on the seams and steering components.This silicone oil resulted in the friction based steering components slipping when released which is why the polarsheath was not able to maintain deflection.The reported clinical observations of loss of deflection and damage were confirmed through cis analysis, but the observation of a detached piece of plastic was not confirmed.The device was found to be intact with no missing pieces.
 
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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 Key18356643
MDR Text Key331194115
Report Number2124215-2023-71835
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeKS
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,Followup
Report Date 03/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number0031909617
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/20/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/28/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age63 YR
Patient SexFemale
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