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	08/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.During a percutaneous transluminal angioplasty in the central vein, a mustang balloon catheter was advanced for dilation.However, during inflation while reaching the rated burst pressure, the balloon burst.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.During a percutaneous transluminal angioplasty in the central vein, a mustang balloon catheter was advanced for dilation.However, during inflation while reaching the rated burst pressure, the balloon burst.No patient complications were reported.It was further reported that the target lesion was 70% stenosed, mildly tortuous and moderately calcified.Furthermore, the balloon ruptured during the second inflation at 18 atmospheres for 40 seconds.Neither the balloon nor a segment of the balloon detached inside the patient after it ruptured.The procedure was completed with another of same device.The patient condition was stable post-procedure.
Additional Manufacturer Narrative
B5: describe event or problem: updated.E1: initial reporter title: updated.E3: occupation: corrected from other health care professional to physician.
Additional Manufacturer Narrative
Updated the following fields.Model number, lot number, catalog number, expiration date, unique identifier (udi) #, and device manufacture date.Describe event or problem: updated.Initial reporter title: updated.Occupation: corrected from other health care professional to physician.
Event or Problem Description
It was reported that balloon rupture occurred.During a percutaneous transluminal angioplasty in the central vein, a mustang balloon catheter was advanced for dilation.However, during inflation while reaching the rated burst pressure, the balloon burst.No patient complications were reported.It was further reported that the target lesion was 70% stenosed, mildly tortuous and moderately calcified.Furthermore, the balloon ruptured during the second inflation at 18 atmospheres for 40 seconds.Neither the balloon nor a segment of the balloon detached inside the patient after it ruptured.The procedure was completed with another of same device.The patient condition was stable post-procedure.It was further reported that the ruptured device used during procedure was a 12.0 x 60, 75cm mustang balloon catheter.
Event or Problem Description
It was reported that balloon rupture occurred.During a percutaneous transluminal angioplasty in the central vein, a mustang balloon catheter was advanced for dilation.However, during inflation while reaching the rated burst pressure, the balloon burst.No patient complications were reported.It was further reported that the target lesion was 70% stenosed, mildly tortuous and moderately calcified.Furthermore, the balloon ruptured during the second inflation at 18 atmospheres for 40 seconds.Neither the balloon nor a segment of the balloon detached inside the patient after it ruptured.The procedure was completed with another of same device.The patient condition was stable post-procedure.It was further reported that the ruptured device used during procedure was a 12.0 x 60, 75cm mustang balloon catheter.
Additional Manufacturer Narrative
Updated the following fields.E3: occupation: corrected from other health care professional to physician.Device evaluated by mfr.: a mustang device was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The rated burst pressure for this device is 14 atmospheres as per mustang specification.Blood was present in the balloon, which is indicative of a leak.The returned device was attached to an encore inflation unit.Positive pressure was applied when di water was observed to be leaking from a balloon pinhole located approximately 1mm distal from the distal markerband.A visual examination of the markerbands identified no issues.A visual and tactile examination identified no kinks or damage to the shaft and identified no damage to the tip.

• 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: 17561398
• Report Number: 2124215-2023-44055
• Device Sequence Number: 12504441
• Product Code: FGE
• UDI-Device Identifier: 08714729794738
• UDI-Public: 08714729794738
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/17/2023

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: 01/19/2026
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0030888523
• 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: 08/10/2023
• Supplement Date Received by Manufacturer: 08/16/2023; 08/25/2023; 10/16/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 08/22/2023; 08/29/2023; 10/17/2023
• 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
• Patient Sex: Unknown