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

Model Number	24673
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: a mustang 7 x 20, 75cm was returned for analysis.The device was returned in three sections as a result of two breaks in the inner shaft.The first break occurred 60mm distal to the proximal markerband.The second break occurred 2mm distal to the distal markerband.It is noted that the broken inner shaft was severely stretched.As a result of the breaks, part of the balloon was received separated from the shaft.The recommended introducer/guide sheath size for this device as per mustang product is minimum 5fr.The customers sheath was not returned.An examination of the balloon identified a complete circumferential tear in the balloon material.The tear was located in the mid-section of the balloon material.The balloon was fully bonded on the proximal and distal balloon bond sides.A portion of the balloon inner shaft was completely detached from both the shaft of the device and the balloon material.Distal markerband was present on this portion.This portion of shaft was severely stretched and accordioned.Shaft detached 620mm from distal end of strain relief.The remaining balloon material with tip attached.Tip was found to be stretched and damaged.All damage was confirmed in balloon region of device.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 17nov2020.It was reported that advancing difficulties occurred.The 90% stenosed target lesion was located in a mildly tortuous and severely calcified superficial femoral artery.A 7.0 x 200, 75cm mustang balloon catheter was advanced for dilatation.However, during the procedure there was a problem with advancing the catheter.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.However, returned device analysis revealed balloon rupture and shaft break.

• 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: 10936920
• Report Number: 2134265-2020-16822
• Device Sequence Number: 19705580
• Product Code: LIT
• UDI-Device Identifier: 08714729794189
• UDI-Public: 08714729794189
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K103751
• 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
• Report Date (Section B): 12/02/2020

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: 04/22/2023
• Device Model Number: 24673
• Device Catalogue Number: 24673
• Device Lot Number: 0025461100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR