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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 0028821162
Device Problem Leak/Splash (1354)
Patient Problem Non specific EKG/ECG Changes (1817)
Event Date 08/24/2022
Event Type  malfunction  
Event Description
It was reported that during a cryo-ablation procedure using a polarsheath, the patient experienced st segment elevation when the balloon catheter was inserted into the patient, through the sheath.They removed the balloon catheter and confirmed the elevation and there was blood leaking from the hemostatic valve.There was concern that air may have made it into the patient, however, no interventions were performed as the st elevation resolved spontaneously.Because the issue resolved on its own imaging was not able to be performed before it resolved, thus they could not confirm if air was present inside the patient.The procedure was completed with no further patient complications and no interventions.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 which found nothing abnormal.Next, the sheath was put through procedural testing by replicating aspiration.The sheath passed this aspiration test as no air was visible in the flushing line any of the times the syringe was drawn.The next procedural test examined the hemostatic valve, which found the sheath was able to maintain pressure without any devices across the valve.Finally, they gently pressurized the sheath, while the distal tip was plugged, and the pressure decay value indicated a 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, the patient experienced st segment elevation when the balloon catheter was inserted into the patient, through the sheath.They removed the balloon catheter and confirmed the elevation and there was blood leaking from the hemostatic valve.There was concern that air may have made it into the patient, however, no interventions were performed as the st elevation resolved spontaneously.Because the issue resolved on its own imaging was not able to be performed before it resolved, thus they could not confirm if air was present inside the patient.The procedure was completed with no further patient complications and no interventions.The sheath has been received at boston scientific 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 Key15431037
MDR Text Key304538735
Report Number2124215-2022-36239
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 10/19/2022
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 Date12/19/2022
Device Lot Number0028821162
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/24/2022
Initial Date FDA Received09/15/2022
Supplement Dates Manufacturer Received09/29/2022
Supplement Dates FDA Received10/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/07/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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