Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH; VASCULAR GUIDE CATHETER, SINGLE-USE Back to Search Results
Lot Number 0031613527
Device Problems Use of Device Problem (1670); Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2023
Event Type  malfunction  
Event Description
It was reported that during a percutaneous catheter myocardial cryoablation procedure a crbs polarsheath steerable sheath was selected for use.After the balloon was inserted in the sheath, aspiration was perfermed.It was confirmed that air was visible in the sheath.The device was replaced and the procedure was completed successfully.No patient complications were reported.The device is expected to return for laboratory analysis.
 
Event Description
It was reported that during a percutaneous catheter myocardial cryoablation procedure a crbs polarsheath steerable sheath was selected for use.After the balloon was inserted in the sheath, aspiration was perfermed.It was confirmed that air was visible in the sheath.The device was replaced and the procedure was completed successfully.No patient complications were reported.The device is expected to return for laboratory analysis.
 
Manufacturer Narrative
Visual examination revealed no visual anomalies observed.3-way stop cock was returned attached to device.The polarsheath was functionally tested in attempt to recreate the visible air allegation seen in the field.The functional tests include an aspiration, hemostasis, and positive air pressure test.These tests evaluate the performance of the hemostatic valve, some of which are under conditions more rigorous than a clinical setting.The sheath failed all standard manufacturing 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 sheath failed standard manufacturing testing when air was observed in the flush line during the aspiration test.The sheath handle was disassembled to find the area where the leak occurred.Analysis found a leak coming from the hemostatic valve at the proximal end.There was a tear in the hemostatic valve due to an off-center puncture which resulted in the polarsheath leaking.The ifu 51331210 states "do not aspirate via the side port if the sheath lumen is occupied (i.E., by the dilator or components of the cryoablation catheter) as the aspiration may draw air across the sheath valve into the polarsheath." per the complaint summary, "when the balloon catheter was inserted after sheath insertion, a reverse blood flow confirmation was performed." this confirms an attempt to aspirate the polarsheath with the catheter occupying the sheath lumen.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key18155705
MDR Text Key328511531
Report Number2124215-2023-64109
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,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/23/2024
Device Lot Number0031613527
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/13/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/13/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-