MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	H74939171040670
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b pro code (product code): fge, lit.E1 initial reporter facility name: (b)(6) hospital.G4 premarket / 510(k) #: k103751, k110122.
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified arteriovenous fistula.A 4.0 x 60, 75cm mustang balloon catheter was advanced for dilation.During the procedure, the balloon burst upon second inflation at 18 atmospheres for 4 seconds.The procedure was completed with a different device.No complications were reported, and the patient condition following the procedure was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified arteriovenous fistula.A 4.0 x 60, 75cm mustang balloon catheter was advanced for dilation.During the procedure, the balloon burst upon second inflation at 18 atmospheres for 4 seconds.The procedure was completed with a different device.No complications were reported, and the patient condition following the procedure was stable.
Additional Manufacturer Narrative
D2b pro code (product code): fge, lit.E1 initial reporter facility name: (b)(6).G4 premarket / 510(k) #: k103751, k110122.Device evaluated by mfr.: the device was returned for analysis.A visual examination of the returned device found that the balloon had been inflated and was not refolded.The balloon was inflated to its rated burst pressure of 24 atm with no leaks or issues noted.A visual 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.

• Brand Name: MUSTANG
• Common Device Name: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• 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: 20753647
• Report Number: 2124215-2024-73423
• Device Sequence Number: 18248362
• Product Code: FGE
• UDI-Device Identifier: 08714729794349
• UDI-Public: 08714729794349
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/10/2024

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: 09/27/2025
• Device Model Number: H74939171040670
• Device Catalogue Number: H74939171040670
• Device Lot Number: 0030233872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2022
• 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 Age: 60 YR
• Patient Sex: Unknown
• Patient Weight: 70 KG