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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 0028832054
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/22/2022
Event Type  malfunction  
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 they observed air while they were checking blood flow.After the sheath was inserted into the patient's body they removed the dilator and guidewire, and when checking blood flow they observed air being withdrawn.They attempted to aspirate the air out of the sheath, however, they were unable to completely clear it.The sheath was exchanged and the procedure was completed without patient complications.The sheath has been received and is awaiting analysis.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory the sheath was first visually inspected which found nothing abnormal.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.The kind of leak seen in the testing can lead to air being observed in the sheath during use.
 
Event Description
It was reported that during a cryo ablation procedure using a polarsheath they observed air while they were checking blood flow.After the sheath was inserted into the patient's body they removed the dilator and guidewire, and when checking blood flow they observed air being withdrawn.They attempted to aspirate the air out of the sheath, however, they were unable to completely clear it.The sheath was exchanged and the procedure was completed without patient complications.The sheath has been received at boston scientific's post market laboratory and analysis is completed.
 
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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 Key15165629
MDR Text Key300902949
Report Number2134265-2022-08364
Device Sequence Number1
Product Code DRF
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
Report Date 09/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/20/2022
Device Lot Number0028832054
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/22/2022
Initial Date FDA Received08/04/2022
Supplement Dates Manufacturer Received09/07/2022
Supplement Dates FDA Received09/24/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/08/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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