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

Model Number	24674
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in superior vena cava.A 5.0 x 100, 135cm mustang balloon catheter was advanced for dilatation.However, when the balloon was drawn out of the blood vessel, the balloon cavity was dripping blood outward.When it was tested with the pressure pump on the operating table, the balloon was found to be leaking blood and balloon pinhole was noted.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: a mustang 5.0 x 100, 135cm, batch # 26332933 was received for analysis.Confirmation has been received that the correct device was returned under this complaint and ncpr # (b)(4) is cancelled.The investigator successfully loaded a boston scientific guidewire through the mustang device and removed it without resistance.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 4mm proximal of the proximal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.As per mustang 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 visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged and present on the shaft of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in superior vena cava.A 5.0 x 100, 135cm mustang balloon catheter was advanced for dilatation.However, when the balloon was drawn out of the blood vessel, the balloon cavity was dripping blood outward.When it was tested with the pressure pump on the operating table, the balloon was found to be leaking blood and balloon pinhole was noted.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient was stable.

• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12741786
• Report Number: 2134265-2021-13706
• Device Sequence Number: 14572674
• Product Code: FGE
• UDI-Device Identifier: 08714729793533
• UDI-Public: 08714729793533
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2021

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: 11/10/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026332933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 11/26/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2020
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 70 KG