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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; VASCULAR GUIDE CATHETER, SINGLE-USE
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BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH; VASCULAR GUIDE CATHETER, SINGLE-USE Back to Search Results
Lot Number 0031363320
Device Problem Air/Gas in Device (4062)
Patient Problems Air Embolism (1697); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/19/2023
Event Type  malfunction  
Event Description
It was reported that during a cryo-ablation procedure using a polarsheath, air was seen in the sheath.The procedure was in progress with the catheter in place inside the sheath.No air was seen in the patient.They exchanged the sheath, and the issue was resolved.The procedure was then completed with no patient complications.The sheath is expected to be returned for analysis.
 
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 during a cryo-ablation procedure using a polarsheath, air was seen in the sheath.The procedure was in progress and the catheter was in place inside the sheath.An air embolism was reported; however, no interventions were required.They exchanged the sheath, and the issue was resolved.The procedure was then completed with no patient complications.The sheath is expected to be returned for analysis.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory the sheath was first visually inspected, and it was noted the puncture slits of the hemostatic valve were slightly off center and the valve was torn.Next, the sheath was put through procedural testing by replicating aspiration.The sheath failed this aspiration test as air was visible in the flushing line each time the syringe was drawn.The next procedural test examined the hemostatic valve, which found the sheath was not able to maintain pressure even when there was nothing across the valve.Finally, they gently pressurized the sheath, while the distal tip was plugged, and the pressure decay value indicated a gross leak of the hemostatic valve.With all the available information boston scientific concludes the allegation of "air observed in the sheath" is confirmed.An off-center valve slit can lead to tearing and may result in the kind of air ingress observed in the field.
 
Event Description
It was reported that during a cryo-ablation procedure using a polarsheath, air was seen in the sheath.The procedure was in progress and the catheter was in place inside the sheath.An air embolism was reported; however, no interventions were required.They exchanged the sheath, and the issue was resolved.The procedure was then completed with no patient complications.The sheath is expected to be returned for analysis.
 
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Brand Name
POLARSHEATH
Type of Device
VASCULAR GUIDE CATHETER, SINGLE-USE
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 Key18040571
MDR Text Key327051181
Report Number2124215-2023-60435
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
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,Followup
Report Date 01/04/2024
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 Expiration Date02/13/2024
Device Lot Number0031363320
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/25/2023
Initial Date FDA Received10/31/2023
Supplement Dates Manufacturer Received10/25/2023
12/15/2023
Supplement Dates FDA Received11/17/2023
01/04/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/04/2023
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) Other;
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