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	04/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the non-tortuous and non-calcified iliac vein.A 12.0 x 80, 135cm mustang balloon catheter was advanced for dilation.However, during the second inflation at 10 atmospheres for 30 second, the balloon ruptured.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported and patient condition was stable.
Additional Manufacturer Narrative
(b)(6).
Additional Manufacturer Narrative
Device evaluated by mfr.: a visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.Blood was identified inside the balloon which is evidence of a device leak.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 15mm distal of the distal markerband.The rated burst pressure for this device is 14 atmospheres as per mustang specification.A visual examination observed no issues or damage to the tip of the device.A visual and tactile examination found no kinks or damage 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.(e1) (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the non-tortuous and non-calcified iliac vein.A 12.0 x 80, 135cm mustang balloon catheter was advanced for dilation.However, during the second inflation at 10 atmospheres for 30 second, the balloon ruptured.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported and patient condition was stable.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17007170
• Report Number: 2124215-2023-25059
• Device Sequence Number: 7150882
• Product Code: FGE
• UDI-Device Identifier: 08714729795285
• UDI-Public: 08714729795285
• 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): 06/23/2023

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: 07/20/2025
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0029796686
• 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: 05/11/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2022
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 52 KG