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

Model Number	24672
Medical Device Problem Codes	Difficult to Remove (1528); 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	05/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a balloon rupture and difficulty in removal occurred.A 7.0 x 150, 75cm mustang balloon catheter was selected for a fistula declot.It was advanced for dilatation.The balloon was inflated once but did not reach its nominal pressure before it burst and became lodged, making removal from the sheath impossible.The doctor attempted to remove the balloon but was unsuccessful.Consequently, vascular surgery was called, and the patient required emergency surgery for removal.The patient underwent an emergency cutdown procedure, and the mustang balloon was successfully removed.No further complications were reported for the patient.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.A visual and tactile examination found the shaft of the device to have completely detached at two locations.The first break was located approximately 80mm proximal from the distal tip.The second break was located approximately 460mm proximal of the first break in the shaft.The third part of the shaft that had the hub attached was not returned.Multiple inner shaft kinks was noted.Severe stretching damage was noted on the inner shaft.This type of damage is consistent with excessive tensile force being applied to the device.A visual examination observed no damage to the tip of the device.The distal markerband was detached from the shaft and not returned with the device.
Event or Problem Description
It was reported that a balloon rupture and difficulty in removal occurred.A 7.0 x 150, 75cm mustang balloon catheter was selected for a fistula declot.It was advanced for dilatation.The balloon was inflated once but did not reach its nominal pressure before it burst and became lodged, making removal from the sheath impossible.The doctor attempted to remove the balloon but was unsuccessful.Consequently, vascular surgery was called, and the patient required emergency surgery for removal.The patient underwent an emergency cutdown procedure, and the mustang balloon was successfully removed.No further complications were reported for the patient.

• 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: 19533421
• Report Number: 2124215-2024-35137
• Device Sequence Number: 20720340
• Product Code: LIT
• UDI-Device Identifier: 08714729794578
• UDI-Public: 08714729794578
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/19/2026
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0030888373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown