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	07/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a shunt in the moderately tortuous and moderately calcified intra-forearm.A 4.0 x 40, 40cm mustang balloon catheter was advanced for dilatation.Inflation was performed at 10 atmospheres for 60 seconds and subsequently at 18 atmospheres for 10 seconds.However, during the second inflation, the balloon ruptured and a pinhole was noted around the center.The device was removed and the procedure was completed with another of same device.No patient complications were reported and the patient was in good condition post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: a mustang device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon 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 pinhole in the shaft located approximately 8mm proximal from the proximal markerband.There were no leaks from balloon material when inflated and visually no issues.A visual examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft which may have potentially contributed to the complaint incident.A leak test identified a prox bond leak.A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a shunt in the moderately tortuous and moderately calcified intra-forearm.A 4.0 x 40, 40cm mustang balloon catheter was advanced for dilatation.Inflation was performed at 10 atmospheres for 60 seconds and subsequently at 18 atmospheres for 10 seconds.However, during the second inflation, the balloon ruptured and a pinhole was noted around the center.The device was removed and the procedure was completed with another of same device.No patient complications were reported and the patient was in good condition post procedure.

• 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: 15075464
• Report Number: 2124215-2022-26536
• Device Sequence Number: 14781011
• Product Code: FGE
• UDI-Device Identifier: 08714729794103
• UDI-Public: 08714729794103
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103751
• 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): 08/23/2022

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: 04/27/2025
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0029301944
• 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: 07/15/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE USED: RADIFOCUS; GUIDEWIRE USED: RADIFOCUS; INFLATION DEVICE USED: ENCORE 26; INFLATION DEVICE USED: ENCORE 26; INTRODUCER SHEATH USED: 5F; INTRODUCER SHEATH USED: 5F
• Patient Sex: Unknown