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

Model Number	24673
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that balloon rupture occurred.A 4.0 x 200, 135cm mustang balloon catheter was advanced for dilation through a 0.035 guidewire.During the procedure, the balloon was inflated with the encore inflation device at a nominal pressure, however, it was immediately noted that the balloon is deflating through a hole located at the distal end.The procedure was completed with a similar device.No complications were reported.
Additional Manufacturer Narrative
B3: date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr.: the mustang was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A leak test identified a balloon pinhole located at the distal markerband.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual and tactile examination found the tip of the device to be severely damaged.This type of damage is consistent with resistance being encountered when crossing a challenging lesion.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged in the correct position on the device.
Event or Problem Description
It was reported that balloon rupture occurred.A 4.0 x 200, 135cm mustang balloon catheter was advanced for dilation through a 0.035 guidewire.During the procedure, the balloon was inflated with the encore inflation device at a nominal pressure, however, it was immediately noted that the balloon is deflating through a hole located at the distal end.The procedure was completed with a similar device.No complications were reported.

• 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: 18607512
• Report Number: 2124215-2024-04589
• Device Sequence Number: 11443646
• Product Code: LIT
• UDI-Device Identifier: 08714729793595
• UDI-Public: 08714729793595
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 05/02/2024

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: 24673
• Device Catalogue Number: 24673
• Device Lot Number: 0030233909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 05/02/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INFLATION DEVICE: ENCORE.; INFLATION DEVICE: ENCORE.
• Patient Sex: Unknown