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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC ARTHROPLASTY BALLOON MUSTANG BALLOON

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BOSTON SCIENTIFIC ARTHROPLASTY BALLOON MUSTANG BALLOON Back to Search Results
Model Number H74939171100470
Device Problems Burst Container or Vessel ; Defective Device
Event Date 08/03/2017
Event Type  Injury  
Event Description

Initially reported as a voluntary (b)(6). During right forearm av fistula arthroplasty, the 10mm diameter angioplasty balloon ruptured despite it only being inflated to 10 atm of pressure. Most pieces were successfully retrieved using snare retrieval procedure, however 1mm foreign body was identified within the right basilic vein which could not be successfully retrieved despite multiple attempts using a variety of catheter-based devices. While this piece was initially left in, it was not limiting flow to brachiocephalic vein, however with the known thrombosis it did place the pt at risk for subsequent thrombosis. Four days later on (b)(6) 2017, pt returned to operating room for subsequent surgical procedure and definitive removal of remaining piece of angioplasty balloon. Surgery successful, pt discharged without further complications. Ref voluntary report #mw5071540.

 
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Brand NameARTHROPLASTY BALLOON
Type of DeviceMUSTANG BALLOON
Manufacturer (Section D)
BOSTON SCIENTIFIC
castle rock CO 80108
MDR Report Key6864935
Report Number6864935
Device Sequence Number1
Product CodeLIT
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 08/30/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/14/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2017
Device MODEL NumberH74939171100470
Device LOT Number20327135
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/30/2017
Distributor Facility Aware Date08/07/2017
Device Age na
Event Location Hospital
Date Report TO Manufacturer08/30/2017
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 09/14/2017 Patient Sequence Number: 1
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