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

Model Number	24674
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulties were encountered and balloon detachment occurred.The target lesion was located in a vessel of the left upper arm.A 8.0 x 100, 75cm mustang balloon was advanced for dilatation.However, during removal, there was difficulty removing the device from the wire which was still in the patient's body.Eventually, the device was removed but it was observed that the proximal end was not on the balloon shaft.Angiogram was performed and the physician used a retrieval device to retrieve the detached portion.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
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 removal difficulties were encountered and balloon detachment occurred.The target lesion was located in a vessel of the left upper arm.A 8.0 x 100, 75cm mustang balloon was advanced for dilatation.However, during removal, there was difficulty removing the device from the wire which was still in the patient's body.Eventually, the device was removed but it was observed that the proximal end was not on the balloon shaft.Angiogram was performed and the physician used a retrieval device to retrieve the detached portion.The procedure was completed with another of the same device.No patient 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 manufacturer.A mustang device was returned for analysis.The device was received inserted in the customer's sheath, which was noted to be damaged at the tip of the sheath.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A full balloon circumferential tear was identified located approximately 45mm proximal of the distal tip.A visual examination of the markerbands identified that the distal markerband was detached and not returned with the device.A visual examination identified that the shaft was detached 4mm proximal from the distal tip.The shaft was also noted to be stretched at the inner shaft.A visual and tactile examination identified no damage to the tip.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15525731
• Report Number: 2124215-2022-35917
• Device Sequence Number: 20331265
• Product Code: FGE
• UDI-Device Identifier: 08714729793700
• UDI-Public: 08714729793700
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K141521
• 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): 10/31/2022

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: 11/01/2024
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0028308795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/07/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 10/01/2022
• Supplement Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male