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

Model Number 39540

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2020

Event Type  malfunction  

Event 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.

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 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
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10443366
• MDR Text Key: 204050563
• Report Number: 2134265-2020-11536
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729829256
• UDI-Public: 08714729829256
• Combination Product (y/n): N
• PMA/PMN Number: K122394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 72