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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 24672
Device Problem Material Rupture (1546)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/17/2020
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified superficial femoral artery.A 4.0 x 150, 135cm mustang balloon catheter was advanced for dilatation.However, during initial inflation, the balloon pressure could not maintain.It was noted that the pressure was 4 atmospheres and lasted for 5 seconds.When the device was removed, it was noticed that the balloon was ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
 
Event Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified superficial femoral artery.A 4.0 x 150, 135cm mustang balloon catheter was advanced for dilatation.However, during initial inflation, the balloon pressure could not maintain.It was noted that the pressure was 4 atmospheres and lasted for 5 seconds.When the device was removed, it was noticed that the balloon was ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: mustang device - 4x15x135 was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A microscopic examination identified a balloon pinhole located approximately 14mm proximal of the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.No other issues were identified during 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 Key11092204
MDR Text Key224397299
Report Number2134265-2020-18563
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729793694
UDI-Public08714729793694
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,distri
Type of Report Initial,Followup
Report Date 02/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/20/2023
Device Model Number24672
Device Catalogue Number24672
Device Lot Number0025524763
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2021
Date Manufacturer Received01/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age83 YR
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