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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 Problems Difficult to Flush (1251); Device Contamination with Body Fluid (2317)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2020
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 the polarsheath were used in a polarx cryo-balloon procedure.It was noted that when the nurse first introduced the dilator inside the sheath, it was scraping and hard to introduce.The physician also said the balloon was more difficult to introduce than usual.Then on the last vein (right inferior pulmonary vein), they noticed that blood was coming backwards inside the tubing of the sheath.The pump used for flushing the sheath was not able to flush forward, saying that it faced an "occlusion".The procedure was completed with no complications being reported.
 
Manufacturer Narrative
Dimensional inspection of the device showed that the valve housing was inspected using gauge pins to assess the minor diameter.This location is the minimum pass through point for the dilator and polarx during clinical use.The inner diameter of the valve sheath housing was smaller than the passing manufacturing specification.There also appeared to be a material that was removed by inserting the gauge pins that were used to test the inner diameter.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
Event Description
It was reported that the polarsheath were used in a polarx cryo-balloon procedure.It was noted that when the nurse first introduced the dilator inside the sheath, it was scraping and hard to introduce.The physician also said the balloon was more difficult to introduce than usual.Then on the last vein (right inferior pulmonary vein), they noticed that blood was coming backwards inside the tubing of the sheath.The pump used for flushing the sheath was not able to flush forward, saying that it faced an "occlusion".The procedure was completed with no complications being reported.
 
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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 Key11050984
MDR Text Key223591273
Report Number2134265-2020-18285
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 company representative,foreig
Type of Report Initial,Followup
Report Date 03/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/19/2021
Device Model NumberM004CRBS3050
Device Lot Number0025830926
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2021
Date Manufacturer Received02/16/2021
Patient Sequence Number1
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