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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
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BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH Back to Search Results
Model Number M004CRBS3050
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Fall (1848); Laceration(s) (1946); Pain (1994)
Event Date 12/08/2020
Event Type  Injury  
Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
 
Event Description
Clinical study (b)(6).It was reported that during or following a cryoablation procedure with a polarsheath and polarx balloon, the patient experienced a cerebellar infarction left.The patient fell at 16:00 pm, and suffered an abrasion and pain in puncture site "a.Fem." the patient underwent a computerized tomography (ct) scan; the results were not reported.No corrective actions were reported and the event was ongoing.The suspected cause was reported as unknown.The device is not expected to be returned for analysis.
 
Manufacturer Narrative
It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.It was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.
 
Event Description
Clinical study polar ice py003.It was reported that during or following a cryoablation procedure with a polarsheath and polarx balloon catheter, the patient experienced a cerebellar infarction left.The patient fell at 16:00pm, and suffered an abrasion and pain in puncture site "a.Fem." the patient underwent a computerized tomography (ct) scan; the results were not reported.No corrective actions were reported and the event was ongoing.The suspected cause was reported as unknown.The device is not expected to be returned for analysis.It was further reported that the procedural activated clotting time (act) was 318 and heparin was given (13.000 iu).
 
Event Description
Clinical study polar ice py003.It was reported that during or following a cryoablation procedure with a polarsheath and polarx balloon catheter, the patient experienced a cerebellar infarction left.The patient fell at 16:00pm, and suffered an abrasion and pain in puncture site "a.Fem." the patient underwent a computerized tomography (ct) scan; the results were not reported.The procedural activated clotting time (act) was 318 and heparin was given (13.000 iu), it was further reported additional heparin was given (12.000 iu) and the event resolved.No additional patient complications were reported.The device is not expected to be returned for analysis.
 
Manufacturer Narrative
It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.It was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.
 
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Brand Name
POLARSHEATH
Manufacturer (Section D)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
302 parkway
global park, la aurora
heredia
CS 
MDR Report Key11116966
MDR Text Key225099184
Report Number2134265-2020-18756
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Type of Report Initial,Followup,Followup
Report Date 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/22/2021
Device Model NumberM004CRBS3050
Device Lot Number0025999166
Was Device Available for Evaluation? No
Date Manufacturer Received03/12/2021
Patient Sequence Number1
Treatment
POLARX; POLARX
Patient Outcome(s) Other;
Patient Age81 YR
Patient Weight90
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