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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 0031079376
Device Problems Difficult to Flush (1251); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2023
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 the luer on the side port detached.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.
 
Event Description
It was reported that during a cryo ablation procedure using a polarsheath the luer on the side port detached.They exchanged the sheath, and the issue was resolved.The procedure was then completed with no patient complications.The sheath has been received by boston scientific for analysis.
 
Manufacturer Narrative
Upon receipt at boston scientific's post market laboratory the sheath was visually inspected which revealed that the irrigation luer was completely separated from the flush lumen.This irrigation luer had not been returned with the rest of the sheath.Adhesive was found on the flush lumen; however, it was noted that the trace adhesive present would be inadequate in adhering the luer to the flush lumen tubing.The reported allegation of irrigation failure was confirmed, and the root cause for the occlusion was traced to manufacturing deficiency due to the inadequate adhesive amount.Separated tubing would prevent irrigation fluid from entering the sheath and proper irrigation would be unable to occur.
 
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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 Key18059414
MDR Text Key327211480
Report Number2124215-2023-60430
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 12/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/30/2023
Device Lot Number0031079376
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/13/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/18/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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