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

Model Number	24674
Medical Device Problem Codes	Inflation Problem (1310); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that hole on the shaft occurred.The target lesion was located in an artery of the upper extremity.A 5.0 x 60, 75cm mustang balloon catheter was advanced for dilation.However, when the balloon was inserted into the lesion, the encore could not dilate the balloon.It was found that the shaft of the balloon has a pinhole which contributed to leaking liquid.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.
Additional Manufacturer Narrative
A mustang 5.0 x 60, 75cm, 24atm was received for analysis.A visual examination identified inflation media within the balloon which indicates that the device was subjected to positive pressure.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 18mm proximal of the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.As per mustang specification, the rated burst pressure for this device is 24 atmospheres.A visual examination observed no issues or damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.A leak test did not identify any leak or rupture to the shaft of the device.No issues were noted with the shaft of the device during analysis.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged and in the correct position on the shaft of the device.
Event or Problem Description
It was reported that hole on the shaft occurred.The target lesion was located in an artery of the upper extremity.A 5.0 x 60, 75cm mustang balloon catheter was advanced for dilation.However, when the balloon was inserted into the lesion, the encore could not dilate the balloon.It was found that the shaft of the balloon has a pinhole which contributed to leaking liquid.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.It was further reported that the target lesion was 70% stenosed, non-tortuous and mildly calcified.The balloon was used within a placed stent.

• 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: 15644556
• Report Number: 2124215-2022-40649
• Device Sequence Number: 6037022
• Product Code: FGE
• UDI-Device Identifier: 08714729793977
• UDI-Public: 08714729793977
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2022

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: 02/17/2025
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0028891608
• 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: 09/29/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2022
• 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: 30 YR
• Patient Sex: Male
• Patient Weight: 68 KG