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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG; CATHETER, BILIARY, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION MUSTANG; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number 24673
Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problem No Code Available (3191)
Event Date 10/18/2019
Event Type  Injury  
Event Description
It was reported that a balloon rupture and detachment occurred.The target lesion was a severely calcified, non-tortuous, total occlusion located in the superficial femoral artery(sfa).A 6.0 x 200, 75cm mustang balloon catheter was advanced to the lesion and inflated.On the first inflation the balloon ruptured circumferentially at a pressure of 10-12 atm.While pulling on the balloon to get it through the sheath the balloon catheter broke into two pieces at the balloon section.They attempted to remove the broken piece but were not successful.Due to the flow the broken piece moved into the knee.The patient was transferred to the operating room, where the broken balloon piece was removed by atherectomy in the popliteal artery.Two non-bsc stents were then placed in the sfa and blood flow was restored.That night the out flow vessels below the knee thrombosed and the patient presented the following day with a white leg due to acute ischemia.Two days later the decision was made to amputate the leg above the knee.No further patient complications were reported.
 
Event Description
It was reported that a balloon rupture and detachment occurred.The target lesion was a severely calcified, non-tortuous, total occlusion located in the superficial femoral artery(sfa).A 6.0 x 200, 75cm mustang balloon catheter was advanced to the lesion and inflated.On the first inflation the balloon ruptured circumferentially at a pressure of 10-12 atm.While pulling on the balloon to get it through the sheath the balloon catheter broke into two pieces at the balloon section.They attempted to remove the broken piece but were not successful.Due to the flow the broken piece moved into the knee.The patient was transferred to the operating room, where the broken balloon piece was removed by atherectomy in the popliteal artery.Two non-bsc stents were then placed in the sfa and blood flow was restored.That night the out flow vessels below the knee thrombosed and the patient presented the following day with a white leg due to acute ischemia.Two days later the decision was made to amputate the leg above the knee.No further patient complications were reported.
 
Manufacturer Narrative
A mustang 6.0 x 200, 75 cm device was returned for analysis.A visual examination identified that the balloon material was returned completely detached from the device.A section of the balloon material measuring approximately 5 mm remained attached to the proximal balloon bond, the edges of the section of the balloon material appeared stretched indicating that force could have been applied to cause the tear.A microscopic examination identified that the distal section of the balloon material was torn circumferentially at both distal and proximal ends.A longitudinal tear was also observed beginning on one end of the balloon material and extending for approximately 120 mm across the balloon material.A visual and microscopic examination observed that the extreme distal shaft section including both markerbands and tip were not returned for analysis therefore no assessment of the tip or markerbands could not be carried out.A visual and tactile examination found that the device was brought in 3 pieces, shaft broken on 3 locations and the extreme section of the shaft was not returned for analysis.Detached sections of the shaft were severely stretched and the shaft distal of the proximal balloon bond was also severely stretched.Damages to the shaft are consistent with excessive force that could have been applied to the shaft during withdrawal attempts.No other issues were identified during the product analysis.
 
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Brand Name
MUSTANG
Type of Device
CATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9317844
MDR Text Key166439252
Report Number2134265-2019-13472
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729794509
UDI-Public08714729794509
Combination Product (y/n)N
PMA/PMN Number
K103751
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24673
Device Catalogue Number24673
Device Lot Number0023550525
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2019
Date Manufacturer Received12/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
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