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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION RUBICON 35 CATHETER, PERCUTANEOUS Back to Search Results
Model Number H74939240035130
Device Problems Material Frayed (1262); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Patient Problem Insufficient Information (4580)
Event Date 03/10/2021
Event Type  Injury  
Event Description

Elderly female with 1-month history of gangrene of the left 4th and 5th toes. Attempted crossing of left superficial femoral artery (sfa) chronic total occlusion; v-14 wire inside a rubicon catheter inside the patient. The wire was stuck and as it was pulled back. Tip of the wire broke off being left behind in the patient. A second v-14 wire to continue to work on the patient¿s leg, this wire as well got stuck. The wire had to pulled out with the catheter to avoid another tip of a wire being left behind. After the wire was assessed it was determined that the tip had not completely detached. The rubicon catheter also had some fraying which may have caused the wires to fray. "a v-14 wire was directed down the quick cross catheter. I exchanged the 035 quick cross catheter for an 014 rubicon catheter. Multiple attempts were made to cross into the true lumen where the vessel reach constituted. At 1 point the wire tip became stuck at the end of the rubicon catheter and sheared off in the distal left sfa chronic total occlusion. As there was no flow in this segment, i did not bother attempting to retrieve it. I attempted to use another 014 wire but could not cross into the true lumen. Once again, the distal tip of the wire became stuck at the end of the rubicon catheter. I then decided to pull both catheter and wire at the same time out through the sheath. The wire was frayed but intact".

 
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Brand NameRUBICON 35
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key11494290
MDR Text Key240047839
Report Number11494290
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 03/12/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/16/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberH74939240035130
Device LOT Number26506874
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/12/2021
Event Location Hospital
Date Report TO Manufacturer03/16/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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