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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 Fistula (1862); Hematoma (1884); Impotence (1925); Pain (1994)
Event Date 10/22/2020
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 following a cryoablation procedure with a polarsheath, the patient experienced a femoral arterio-venous fistula with moderate impact.The patient's anticoagulant medication was stopped.The event was ongoing.Four days later, the patient was hospitalized due to the ongoing event.The hematoma was in the process of resorption with no sign of leg hypo perfusion.However, persistent femoral murmur was present.The patient also experienced "functional impotence." the patient was given oral paracetamol and their apixaban oral medication was stopped.Two days later, the apixaban was restarted with a decreased dose.The event was ongoing.The suspected cause was the ablation procedure.The device is not expected to be returned.
 
Event Description
Clinical study polar ice py003.It was reported that following a cryoablation procedure with a polarsheath, the patient experienced a femoral arterio-venous fistula with moderate impact.The patient's anticoagulant medication was stopped.The event was ongoing.Four days later, the patient was hospitalized due to the ongoing event.The hematoma was in the process of resorption with no sign of leg hypo perfusion.However, persistent femoral murmur was present.The patient also experienced "functional impotence." the patient was given oral paracetamol and their apixaban oral medication was stopped.Two days later, the apixaban was restarted with a decreased dose.The event was ongoing.The suspected cause was the ablation procedure.The device is not expected to be returned.It was further reported that the patient experienced pain on the right femoral fistula.An echo doppler showed the fistula was still present.The patient's pain was also still present.The patient was scheduled for surgery.
 
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.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
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.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
Event Description
Clinical study polar ice (b)(4): it was reported that following a cryoablation procedure with a polarsheath, the patient experienced a femoral arterio-venous fistula with moderate impact.The patient's anticoagulant medication was stopped.The event was ongoing.Four days later, the patient was hospitalized due to the ongoing event.The hematoma was in the process of resorption with no sign of leg hypo perfusion.However, persistent femoral murmur was present.The patient also experienced "functional impotence." the patient was given oral paracetamol and their apixaban oral medication was stopped.Two days later, the apixaban was restarted with a decreased dose.The event was ongoing.The suspected cause was the ablation procedure.The device is not expected to be returned.It was further reported that the patient experienced pain on the right femoral fistula.An echo doppler on 19nov2020 showed the fistula was still present.The patient's pain was also still present.The patient was scheduled for surgery on (b)(6) 2020.It was further reported that the patient was admitted to the hospital on (b)(6) 2020 and surgery was performed on (b)(6) 2020 and the event resolved.
 
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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 Key10843524
MDR Text Key216352583
Report Number2134265-2020-15877
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 12/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/17/2021
Device Model NumberM004CRBS3050
Device Lot Number0025676920
Was Device Available for Evaluation? No
Date Manufacturer Received12/14/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age62 YR
Patient Weight84
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