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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 5.0 x 150, 135cm mustang balloon catheter was advanced for dilation.During the procedure, on the first inflation at 12 atmospheres for 10 seconds, the balloon ruptured.The device was removed without any problem with no damage found on the balloon.The procedure was completed using another of the same device.No complications reported, and patient status was good.
Additional Manufacturer Narrative
Device evaluated by mfr.: device returned for analysis.The balloon, markerbands, tip, and shaft underwent a visual and tactile examination.The balloon was not folded which indicates that the balloon was subjected to positive pressure.A leak test identified a balloon pinhole located approximately at the centre of the balloon.The rated burst pressure for this device as per specification is 24 atmospheres.There were no kinks or damages found on the shaft and tip of the device.Both markerbands were also undamaged in the correct position on the device.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 5.0 x 150, 135cm mustang balloon catheter was advanced for dilation.During the procedure, on the first inflation at 12 atmospheres for 10 seconds, the balloon ruptured.The device was removed without any problem with no damage found on the balloon.The procedure was completed using another of the same device.No complications reported, and patient status was good.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19274342
• Report Number: 2124215-2024-28078
• Device Sequence Number: 12619935
• Product Code: LIT
• UDI-Device Identifier: 08714729793434
• UDI-Public: 08714729793434
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2024

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: 04/18/2024
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0027161048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown