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	Insufficient Information (4580)
Date of Event	07/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred requiring intervention.The target lesion was located in highly tortuous coronary artery.A 135cm rubicon 35 guide catheter was advanced for use.However, during the procedure, the catheter tip broke off into the patient's aorta.The physician used a snare to retrieve the broken catheter tip and was successfully removed.The procedure was cancelled and there were no patient complications reported.The patient was fully recovered.
Additional Manufacturer Narrative
Device evaluated by mfr.: the rubicon 35 guide catheter was returned to boston scientific for analysis.The device was visually and microscopically inspected for damage.The devices shaft showed a separated shaft located 13.5cm from the tip.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The complaint was confirmed for a separation.
Event or Problem Description
It was reported that tip detachment occurred requiring intervention.The target lesion was located in highly tortuous coronary artery.A 135cm rubicon 35 guide catheter was advanced for use.However, during the procedure, the catheter tip broke off into the patient's aorta.The physician used a snare to retrieve the broken catheter tip and was successfully removed.The procedure was cancelled and there were no patient complications reported.The patient was fully recovered.

• 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: 12286748
• Report Number: 2134265-2021-09745
• Device Sequence Number: 19635769
• Product Code: DQY
• UDI-Device Identifier: 08714729832072
• UDI-Public: 08714729832072
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2024
• Device Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0027229563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention