MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RUBICON 35; CATHETER, PERCUTANEOUS

Model Number	39540
Medical Device Problem Codes	Entrapment of Device (1212); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guide catheter snapped in half.The target lesion was located in the superficial femoral artery.A 135cm rubicon 35 catheter-guide was selected for use.During withdrawal, the rubicon was removed from the patient.Outside the body, the rubicon was tried to removed from an amplatz guidewire, however the rubicon became very tight on the wire.A lot of force was used to get the catheter off of the wire, however, it was noted that the proximal end of the rubicon snapped in half.Both pieces of the device were able to be removed from the wire and the procedure was completed.No patient complications were reported.
Event or Problem Description
It was reported that the guide catheter snapped in half.The target lesion was located in the superficial femoral artery.A 135cm rubicon 35 catheter-guide was selected for use.During withdrawal, the rubicon was removed from the patient.Outside the body, the rubicon was tried to removed from the amplatz guidewire, however the rubicon became very tight on the wire.A lot of force was used to get the catheter off of the wire, however, it was noted that the proximal end of the rubicon snapped in half.Both pieces of the device were able to be removed from the wire and the procedure was completed.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The rubicon showed damage in the form of a complete separation 22.5cm from the distal end.Stretching was seen 12 to 15.5cm from the distal end.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage.Device analysis determined the condition of the returned device was consistent with the reported information of a fracture or separation.

• Brand Name: RUBICON 35
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11956754
• Report Number: 2134265-2021-06884
• Device Sequence Number: 17029865
• Product Code: DQY
• UDI-Device Identifier: 08714729832072
• UDI-Public: 08714729832072
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K122394
• Number of Events Summarized: 1
• 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,Followup
• Report Date (Section B): 07/08/2021

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 Date: 03/17/2024
• Device Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0026805475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1