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

Model Number	24672
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with leg swelling and claudication which lasted for 15 days.The 90% stenosed target lesion was located in the severely tortuous and severely calcified femoral artery.A 3.0x150, 135cm mustang balloon catheter was advanced for dilatation.However, during first inflation at 20 atmospheres for 3 seconds, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and lumen which is evidence of a device leak.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.The balloon could not be inflated due to the presence of solidified blood that was present within the inflation lumen.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the blood before further inflation attempts were made.The device was removed from the bath and the balloon was again attached to an inflation device subjected to positive pressure and liquid was observed to be leaking from a balloon pinhole located at the proximal edge of the distal markerband.An examination of the balloon material and distal markerband identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed to the tip of the device.This type of damage is consistent with excessive force being applied when attempting to cross a lesion.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 or Problem Description
It was reported that balloon rupture occurred.The patient presented with leg swelling and claudication which lasted for 15 days.The 90% stenosed target lesion was located in the severely tortuous and severely calcified femoral artery.A 3.0x150, 135cm mustang balloon catheter was advanced for dilatation.However, during first inflation at 20 atmospheres for 3 seconds, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient was stable.

• 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: 9387748
• Report Number: 2134265-2019-14596
• Device Sequence Number: 469548
• Product Code: LIT
• UDI-Device Identifier: 08714729794516
• UDI-Public: 08714729794516
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2020

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: 05/30/2022
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0023881365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR