MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG; CATHETER, BILIARY, DIAGNOSTIC

Model Number	24674
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the upper vein of the left arm elbow.A 7.0 x 80, 75cm mustang balloon catheter was advanced for dilatation.However, during inflation at 20 atmospheres, the balloon ruptured.The procedure was completed with another of same device.No patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: a mustang 7.0 x 80, 75cm was returned for analysis.A longitudinal balloon tear was identified starting 3mm distal of the distal markerband and extending 52mm proximally.A visual and microscopic examination of the balloon material identified no other issues.A visual and microscopic examination of the markerbands identified no issues.A visual and tactile examination identified no kinks or damage to the shaft.A visual and tactile examination identified no damage to the tip.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the upper vein of the left arm elbow.A 7.0 x 80, 75cm mustang balloon catheter was advanced for dilatation.However, during inflation at 20 atmospheres, the balloon ruptured.The procedure was completed with another of same device.No patient complications nor injuries reported.It was further reported that the 80% stenosed target lesion was severely tortuous and severely calcified.The balloon ruptured during the initial inflation.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9955616
• Report Number: 2134265-2020-04995
• Device Sequence Number: 16847653
• Product Code: FGE
• UDI-Device Identifier: 08714729794264
• UDI-Public: 08714729794264
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K141521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0024848961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Initial Date Received by Manufacturer: 04/06/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR