MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RUBICON 18; CATHETER, PERCUTANEOUS

Model Number	39540
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was contaminated.The target lesion was located in the superficial femoral artery.A 150cm rubicon 18 was selected for use.During unpacking, it was noted that the bottom of the package was not sealed and the device became contaminated.The procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The rubicon device was visually and microscopically analyzed for any damage.The original sterile packaging was not returned.The device was in the shipping tube when received.The device was removed from the tube and no damage was noticed on the shaft.Inspection of the remainder of the device revealed no damage or irregularities.
Event or Problem Description
It was reported that the device was contaminated.The target lesion was located in the superficial femoral artery.A 150cm rubicon 18 was selected for use.During unpacking, it was noted that the bottom of the package was not sealed and the device became contaminated.The procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.

• Brand Name: RUBICON 18
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10443366
• Report Number: 2134265-2020-11536
• Device Sequence Number: 2726936
• Product Code: DQY
• UDI-Device Identifier: 08714729829256
• UDI-Public: 08714729829256
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K122394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2020

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 Date: 11/15/2022
• Device Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0024779969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 72