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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 0033416243
Device Problem Leak/Splash (1354)
Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817)
Event Date 03/26/2024
Event Type  Injury  
Event Description
It was reported that the patient experienced an st-segment elevation and air embolism.During a cryoablation procedure to treat atrial fibrillation, a polarsheath was selected for use.After using the brockenbrough, the polarsheath was inserted into the left atrium to check for the backflow of blood; no air was observed in the syringe at this time.However, st-segment elevation was confirmed after two to three minutes.An st-segment elevation on the inferior wall lead of the ecg was confirmed.Air embolism was confirmed in the right coronary artery with coronary angiogram.The patient was treated with ventricular pacing and vasopressors.A coronary angiogram was performed while the polarsheath was placed in the left atrium; no air was observed in the right coronary artery at this time.The changes on the st-segment were then confirmed to be resolved and they returned to the procedure.However, st-segment elevation recurred when the balloon catheter was inserted into the polarsheath and advanced.Moreover, air was confirmed when the balloon catheter was removed, and backflow of blood was checked from the polarsheath.A coronary angiogram was performed again, and air embolism was confirmed in the right coronary artery.The changes on the st-segment were then resolved after some time.It was suspected that the polarsheath valve was damaged; therefore, the sheath was replaced and resumed the procedure.The suspected damaged polarsheath and the replacement sheath were flushed by holding its tip with fingers and leakage was observed from the valve of the suspected damaged sheath.No similar event was observed with the replacement sheath.No resistance was felt while operating/removing the device.The procedure was completed with no further complications.The device has been returned for analysis.
 
Manufacturer Narrative
The polarsheath was visually inspected for any damage that would have led to the leak allegation seen in the field.A visible tear was observed in the center of the polarsheath hemostatic valve.The device also failed all functional leak testing, with a leak in the pressure decay test, air in the flush line during the aspiration test and dropping pressure while pressurized at 5.5 psi in hemostasis testing.The polarsheath handle was disassembled to find the area where the leak occurred.Analysis found a leak coming from the hemostatic valve at the proximal end.The tear in the hemostatic valve resulted in the polarsheath leaking.There appeared to be no issues with the valve puncture and valve slits as they were aligned and centered in the valve.The tear is believed to have occurred from normal use during the procedure as no defects were found that would have contributed to the valve tearing.The complaint was confirmed through analysis.
 
Event Description
It was reported that the patient experienced an st-segment elevation and air embolism.During a cryoablation procedure to treat atrial fibrillation, a polarsheath was selected for use.After using the brockenbrough, the polarsheath was inserted into the left atrium to check for the backflow of blood; no air was observed in the syringe at this time.However, st-segment elevation was confirmed after two to three minutes.An st-segment elevation on the inferior wall lead of the ecg was confirmed.Air embolism was confirmed in the right coronary artery with coronary angiogram.The patient was treated with ventricular pacing and vasopressors.A coronary angiogram was performed while the polarsheath was placed in the left atrium; no air was observed in the right coronary artery at this time.The changes on the st-segment were then confirmed to be resolved and they returned to the procedure.However, st-segment elevation recurred when the balloon catheter was inserted into the polarsheath and advanced.Moreover, air was confirmed when the balloon catheter was removed, and backflow of blood was checked from the polarsheath.A coronary angiogram was performed again, and air embolism was confirmed in the right coronary artery.The changes on the st-segment were then resolved after some time.It was suspected that the polarsheath valve was damaged; therefore, the sheath was replaced and resumed the procedure.The suspected damaged polarsheath and the replacement sheath were flushed by holding its tip with fingers and leakage was observed from the valve of the suspected damaged sheath.No similar event was observed with the replacement sheath.No resistance was felt while operating/removing the device.The procedure was completed with no further complications.The device has been returned for analysis.
 
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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 Key19119531
MDR Text Key340309244
Report Number2124215-2024-23024
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 Other,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number0033416243
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/26/2024
Initial Date FDA Received04/16/2024
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/28/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/13/2024
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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