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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RUBICON 35; CATHETER, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION RUBICON 35; CATHETER, PERCUTANEOUS Back to Search Results
Model Number 39540
Medical Device Problem Codes Contamination (1120); Unsealed Device Packaging (1444)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/03/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the sterility of the catheter was compromised.A 135cm rubicon 35 guide catheter was selected for use.During preparation, it was noted that the packaging of the rubicon was not sealed so the sterile integrity was compromised.The procedure was completed with another of same device.No patient complications were reported.
 
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Brand Name
RUBICON 35
Common Device Name
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11863154
Report Number2134265-2021-06245
Device Sequence Number17091286
Product Code DQY
UDI-Device Identifier08714729832072
UDI-Public08714729832072
Combination Product (Y/N)N
Initial Reporter StateKY
Initial Reporter CountryUS
PMA/510(K) Number
K122394
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date02/24/2024
Device Model Number39540
Device Catalogue Number39540
Device Lot Number0026868115
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/03/2021
Initial Report FDA Received Date05/21/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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