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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 0029919068
Device Problem Difficult to Remove (1528)
Patient Problem Non specific EKG/ECG Changes (1817)
Event Date 10/14/2022
Event Type  malfunction  
Manufacturer Narrative
The device has been received but analysis has not yet begun.Upon 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
During a paroxysmal atrial fibrillation (paf) procedure, a polarsheath was selected for use.It was reported that after the procedure was completed, the sheath was temporarily unable to return to its flexion during removal; therefore, it could not be taken out of the body.The sheath's flexion eventually returned, and it was removed from the body after some time.However, it was still not completely straight and remained slightly flexed.An st elevation was observed thereafter.No occlusion was observed, and the patient recovered immediately.The procedure was completed successfully with the original sheath.
 
Event Description
During a paroxysmal atrial fibrillation (paf) procedure, a polarsheath was selected for use.It was reported that after the procedure was completed, the sheath was temporarily unable to return to its flexion during removal; therefore, it could not be taken out of the body.The sheath's flexion eventually returned, and it was removed from the body after some time.However, it was still not completely straight and remained slightly flexed.An st elevation was observed thereafter.No occlusion was observed, and the patient recovered immediately.The procedure was completed successfully with the original sheath.
 
Manufacturer Narrative
The device was received at boston scientific for analysis.The polarsheath was returned with the polarx catheter still inserted into the sheath.The tip of the polarsheath was unable to be fully straightened and whilst attempting to move the sheath's steering knob some slack was observed.It took about 3/4 of a full turn before the steering knob engaged with the tip of the sheath.The reported event was confirmed.
 
Manufacturer Narrative
The device was received at boston scientific for analysis.The polarsheath was returned with the polarx catheter still inserted into the sheath.The tip of the polarsheath was unable to be fully straightened and whilst attempting to move the sheath's steering knob some slack was observed.It took about 3/4 of a full turn before the steering knob engaged with the tip of the sheath.The reported event was confirmed.The polarsheath was observed upon receipt and after functional testing to maintain a slight curvature in the sheath tip.This curvature, however, was not due to any internal factors preventing the tip from straightening.The tip remained curved due to material deformation memory from extended use.There was no resistance straightening that would have led to difficulty withdrawing the device from the patient.Additional slack was observed from the neutral steering position to deflecting the sheath tip.This further proves the steering wire was not under tension deflecting the polarsheath tip.X-ray analysis also showed no defects with the steering mechanism which would have led to it being unable to return to its straightened position.
 
Event Description
During a paroxysmal atrial fibrillation (paf) procedure, a polarsheath was selected for use.It was reported that after the procedure was completed, the sheath was temporarily unable to return to its flexion during removal; therefore, it could not be taken out of the body.The sheath's flexion eventually returned, and it was removed from the body after some time.However, it was still not completely straight and remained slightly flexed.An st elevation was observed thereafter.No occlusion was observed, and the patient recovered immediately.The procedure was completed successfully with the original sheath.
 
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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 Key15752971
MDR Text Key306181133
Report Number2124215-2022-45438
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,Followup
Report Date 02/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/20/2023
Device Lot Number0029919068
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/22/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/09/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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