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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 Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2021
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr. : mustang 6. 0 x 200, 135cm was received for analysis. The device was received in two sections due to a complete shaft break. A visual examination identified that the balloon protector was partially removed from the balloon. The investigator successfully removed the balloon protector from the balloon without issue. A visual and microscopic examination found no issues with the balloon material which could potentially have contributed to the complaint incident. No issues were noted with the tip section of the device. A visual and microscopic examination found no issue with the markerbands. A visual and tactile examination found the shaft of the device to be detached at approximately 15mm proximal of the proximal markerband. This type of damage is consistent with excessive tensile force being applied to the device.
 
Event Description
Reportable based on device analysis completed on 19jan2022. It was reported that shaft damage occurred. The target lesion was located in a fistula in the radial/brachial artery. A 6. 0 x 200, 135cm mustang balloon was selected for use. However, when the physician opened the balloon from the protective cover, the shaft was damaged. The procedure was completed with another of the same device. There were no patient complications reported and the patient was doing good. However, returned device analysis revealed shaft separation.
 
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Brand NameMUSTANG
Type of DeviceCATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
pmt 741 persiaran cassia selat
bandarcassia, pulau pinan 14110
MY 14110
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13508261
MDR Text Key285620977
Report Number2134265-2022-01016
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K103751
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial
Report Date 02/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24673
Device Catalogue Number24673
Device Lot Number0027346479
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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