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	02/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the severely tortuous and severely calcified superficial femoral artery.A 6.0 x 80, 135cm mustang balloon catheter was advanced for dilation but after filled with agent contrast, the balloon could not fully inflate.However, when the balloon was removed and flushed with liquid, it was leaking liquid and pinhole was noted.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: mustang device 6x8x135cm, batch#21759837, 24atm was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A microscopic examination identified a balloon longitudinal tear beginning at the distal end of the distal markerband and extending approximately 4mm proximally across the balloon material.An examination of the balloon material and distal markerband identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 24 atmospheres.A visual and microscopic examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.No other issues were identified during analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the severely tortuous and severely calcified superficial femoral artery.A 6.0 x 80, 135cm mustang balloon catheter was advanced for dilation but after filled with agent contrast, the balloon could not fully inflate.However, when the balloon was removed and flushed with liquid, it was leaking liquid and pinhole was noted.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.

• 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: 11377051
• Report Number: 2134265-2021-02329
• Device Sequence Number: 4038124
• Product Code: FGE
• UDI-Device Identifier: 08714729793793
• UDI-Public: 08714729793793
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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: 02/18/2021
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0021759837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 74