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

Model Number	24673
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.The severely calcified target lesion was located in the superficial femoral artery (sfa).Two non bsc stent balloon were advanced to the target lesion and ruptured.A 5.0 x 200, 135 cm mustang was then used to dilate the target lesion and on the first inflation, under rated burst pressure (rbp), the balloon burst.It was noted that the calcification likely caused the balloon to burst.The procedure was completed with a non bsc device.No patient complications were reported in relation to this event and the patient status was okay.
Additional Manufacturer Narrative
Device evaluated by mfr: a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 55mm distal to the distal end of the proximal markerband.An examination of the balloon material identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed damage to the tip.This type of damage is consistent with excess force being applied as a result of meeting resistance during the attempt to cross a lesion.A visual and tactile examination found the shaft of the device to be kinked at approximately 95mm proximal of the distal markerband.This type of damage is consistent with excessive force being applied to the delivery system.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that a balloon rupture occurred.The severely calcified target lesion was located in the superficial femoral artery (sfa).Two non bsc stent balloon were advanced to the target lesion and ruptured.A 5.0 x 200, 135 cm mustang was then used to dilate the target lesion and on the first inflation, under rated burst pressure (rbp), the balloon burst.It was noted that the calcification likely caused the balloon to burst.The procedure was completed with a non bsc device.No patient complications were reported in relation to this event and the patient status was okay.It was further reported that the 80% stenosed target lesion was located in the short straight lesion and moderately calcified superficial femoral artery (sfa).No patient complications were reported in relation to this event.

• 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: 8604409
• Report Number: 2134265-2019-04950
• Device Sequence Number: 19588161
• Product Code: LIT
• UDI-Device Identifier: 08714729793373
• UDI-Public: 08714729793373
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 06/12/2019

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: 12/16/2021
• Device Model Number: 24673
• Device Catalogue Number: 24673
• Device Lot Number: 0023092131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 06/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1