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

Model Number	39540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the rubicon shaft detached.A 150cm rubicon 35 guide catheter was selected for use.During the procedure, a 300cm v-18 control wire was advanced but failed to cross the lesion.Then another non-bsc guide wire crossed the lesion.A 150cm rubicon guide catheter was advanced in a very heavily calcified lesion in the common femoral artery (cfa) with multiple wire exchanges, it was noted that 10cm of the distal part of the catheter broke and became stuck in the vessel.The broken piece was then snared out of the patient's body.No further patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device eval by manufacturer:returned device consisted of a rubicon 35 separated with 2 pieces returning.The device returned in 2 pieces.The 1st piece was 133cm long from the hub and showed a kinking damage approximately 129.5cm to 131cm from the hub.The 2nd piece was 20cm long.The device as designed is 150cm long.The total pieces that were returned and measured were 153cm long which indicates that there was stretching of the device.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 rubicon shaft detached.A 150cm rubicon 35 guide catheter was selected for use.During the procedure, a 300cm v-18 control wire was advanced but failed to cross the lesion.Then another non-bsc guide wire crossed the lesion.A 150cm rubicon guide catheter was advanced in a very heavily calcified lesion in the common femoral artery (cfa) with multiple wire exchanges, it was noted that 10cm of the distal part of the catheter broke and became stuck in the vessel.The broken piece was then snared out of the patient's body.No further patient complications nor injuries were reported.

• 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: 8147570
• Report Number: 2134265-2018-63783
• Device Sequence Number: 1901028
• Product Code: DQY
• UDI-Device Identifier: 08714729832058
• UDI-Public: 08714729832058
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K122394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2019

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: 10/16/2021
• Device Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0022806483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 01/03/2019
• 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