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

Model Number	39540
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter was broken.A 90cm rubicon 35 guide catheter was selected for use.During preparation, while purging the device, it was noted that the catheter was broken.No anomaly was noted with the pouch prior to use of the device and the pouch was not previously opened.The device did not enter the patient's body and the procedure was completed with another of same device.No patient complications were reported and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The rubicon showed damage in the form of a fracture approx.4.1 cm from the distal end.This was not a complete separation; the catheter was still attached.A kink was seen 3.7 cm from the distal end.Residue was seen in the catheter at the kink.This could be blood or contrast.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage.
Event or Problem Description
It was reported that the catheter was broken.A 90cm rubicon 35 guide catheter was selected for use.During preparation, while purging the device, it was noted that the catheter was broken.No anomaly was noted with the pouch prior to use of the device and the pouch was not previously opened.The device did not enter the patient's body and the procedure was completed with another of same device.No patient complications were reported and the patient was stable post procedure.

• 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: 11826251
• Report Number: 2134265-2021-05889
• Device Sequence Number: 1153648
• Product Code: DQY
• UDI-Device Identifier: 08714729832041
• UDI-Public: 08714729832041
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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: 09/19/2023
• Device Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0026045192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR