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

Model Number	39540
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the distal portion of the catheter broke off and remained inside the patient.The approach was via the contralateral side attempting to cross right common iliac stenosis.The target lesion was located in a moderately tortuous and extremely calcified right common iliac artery.A 90cm rubicon 18 guide catheter was selected for use.During procedure, a.014 wire was passed then an attempt to cross with a 018 rubicon 90cm was made.The rubicon passed into the distal common iliac lesion; however, it would not go any further.After retrieving the rubicon, it was noted that the distal portion of the catheter broke off.The distal tip of the catheter containing 2 markers remained behind in the right common iliac artery.Ultrasound guided access was obtained on right side.A wire was passed from right side into distal aorta.The right common and external iliac artery was pre-dilated.Then a non boston scientific stent was deployed capturing the 018 catheter tip to the vessel wall.Post dilatation was done with a 6x100 mustang balloon.Post angio revealed excellent results with no complications.The procedure was completed with a different device.Patient had brisk flow down common iliac into femoral artery area.No further complication were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The device was visually and microscopically inspected for damage.The devices shaft showed a separated tip located 88.5cm from the strain relief.There were 2 kinks located 87.3cm and 88.7cm from the strain relief.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.
Event or Problem Description
It was reported that the distal portion of the catheter broke off and remained inside the patient.The approach was via the contralateral side attempting to cross right common iliac stenosis.The target lesion was located in a moderately tortuous and extremely calcified right common iliac artery.A 90cm rubicon 18 guide catheter was selected for use.During procedure, a.014 wire was passed then an attempt to cross with a 018 rubicon 90cm was made.The rubicon passed into the distal common iliac lesion; however, it would not go any further.After retrieving the rubicon, it was noted that the distal portion of the catheter broke off.The distal tip of the catheter containing 2 markers remained behind in the right common iliac artery.Ultrasound guided access was obtained on right side.A wire was passed from right side into distal aorta.The right common and external iliac artery was pre-dilated.Then a non boston scientific stent was deployed capturing the 018 catheter tip to the vessel wall.Post dilatation was done with a 6x100 mustang balloon.Post angio revealed excellent results with no complications.The procedure was completed with a different device.Patient had brisk flow down common iliac into femoral artery area.No further complication were reported.

• 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: 11600238
• Report Number: 2134265-2021-03899
• Device Sequence Number: 19885174
• Product Code: DQY
• UDI-Device Identifier: 08714729829232
• UDI-Public: 08714729829232
• Combination Product (Y/N): N
• 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): 05/20/2021

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: 05/01/2021
• Device Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0022065105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 05/01/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 05/20/2021
• 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: Other; Required Intervention