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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RUBICON 14; CATHETER, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION RUBICON 14; CATHETER, PERCUTANEOUS Back to Search Results
Device Problem Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/24/2023
Event Type  malfunction  
Event Description
It was reported that removal difficulties were encountered.A 5.0x80 sterling balloon catheter and.35 rubicon catheter-guide were selected for use.During the procedure, the balloon was placed through the rubicon.However, the balloon became stuck and was difficult to remove from the rubicon.Both devices were removed from the patient and the procedure was completed with a different equipment.No patient complications were reported.
 
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Brand Name
RUBICON 14
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key16991704
MDR Text Key315832417
Report Number2124215-2023-21880
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 05/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/26/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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