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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 Difficult to Insert
Event Date 08/01/2019
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: 18 years or older. Date of event: used (b)(6) 2019 as no event date was provided. Device evaluated by mfr. : a visual and microscopic examination was performed on the returned mustang device. A visual examination of the returned device confirmed that there was a longitudinal tear observed in the balloon material. The longitudinal tear in the balloon stretches for 100mm from the proximal edge of proximal markerband to the middle section of the balloon material. During analysis the investigator did not attempt to advance the device through a 5fr boston scientific sheath due to the condition of the balloon material. A visual and microscopic examination found no damage or any issues with the tip or markerbands of the device which could have contributed to the complaint incident. A visual and tactile examination found no kinks or damage along the shaft of the device. No other issues were identified during the product analysis.

 
Event Description

Reportable based on device analysis completed on 12sep2019. It was reported that insertion difficulty was encountered. A 6. 0 x 200, 75cm mustang balloon catheter was selected for use, but they encountered difficulty in going through the non-bsc 5fr sheath. There were no patient complications reported. However, returned device analysis revealed a longitudinal tear in the balloon.

 
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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
ballybrit business park
galway
EI 
Manufacturer Contact
jay johnson
two scimed place
maple grove , MN 55311
7634942574
MDR Report Key9141270
Report Number2134265-2019-11841
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 10/01/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/01/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number24673
Device Catalogue Number24673
Device LOT Number0022616326
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/26/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/06/2018
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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