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	01/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the iliac artery.A 10.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.However, during inflation at 6 atmospheres, the balloon ruptured.No balloon fragments were left in the patient's body.The procedure was completed with another of same device.No patient complications were reported and the patient condition was fine.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the iliac artery.A 10.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.However, during inflation at 6 atmospheres, the balloon ruptured.No balloon fragments were left in the patient's body.The procedure was completed with another of same device.No patient complications were reported and the patient condition was fine.It was further reported that the target lesion had 60% stenosis and was non-tortuous and mildly calcified.The balloon ruptured upon initial inflation.
Additional Manufacturer Narrative
B5 - describe event or problem updated.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the iliac artery.A 10.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.However, during inflation at 6 atmospheres, the balloon ruptured.No balloon fragments were left in the patient's body.The procedure was completed with another of same device.No patient complications were reported and the patient condition was fine.It was further reported that the target lesion had 60% stenosis and was non-tortuous and mildly calcified.The balloon ruptured upon initial inflation.
Additional Manufacturer Narrative
B5 - describe event or problem updated.Device evaluated by mfr.: mustang device was returned for analysis.The device was received with the hub section detached from the device.The hub was not returned to the cis for analysis.The recommended introducer sheath size for this device is minimum 6fr.The customers sheath was not returned with the device.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A complete balloon circumferential tear was identified located approximately 27mm distal of the proximal markerband.An examination of the balloon material identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip of the device.A visual and tactile examination found the hub of the device to have completely detached 650mm from the proximal markerband.A visual examination found no damage to the markerbands.No other issues were identified during the product analysis.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11266866
• Report Number: 2134265-2021-01106
• Device Sequence Number: 11577344
• Product Code: FGE
• UDI-Device Identifier: 08714729794004
• UDI-Public: 08714729794004
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2021

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: 05/10/2021
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0022105047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 01/31/2021; 04/28/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 02/10/2021; 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR