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 Consequences Or Impact To Patient (2199)
Date of Event	01/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: patient is 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the bracheocephalic fistula.After a 6fr sheath was placed, a 0.035 stiff guidewire was used to cross the lesion.Subsequently, a 5.0 x 40, 135cm mustang balloon catheter was advanced for dilatation.However, the balloon ruptured at 20 atmospheres.A 6.0 x 60, 135cm mustang balloon catheter was advanced for dilatation.However, during inflation at 22 atmospheres, the balloon ruptured again.The procedure was completed with a different device.There were no patient complications reported and patient's status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the bracheocephalic fistula.After a 6fr sheath was placed, a 0.035 stiff guidewire was used to cross the lesion.Subsequently, a 5.0 x 40, 135cm mustang balloon catheter was advanced for dilatation.However, the balloon ruptured at 20 atmospheres.A 6.0 x 60, 135cm mustang balloon catheter was advanced for dilatation.However, during inflation at 22 atmospheres, the balloon ruptured again.The procedure was completed with a different device.There were no patient complications reported and patient's status was stable.It was further reported that the target lesion was 50% stenosed, moderately calcified and not tortuous.The 5.0 x 40, 135cm mustang balloon catheter ruptured during first inflation at 30 seconds.
Additional Manufacturer Narrative
A2: age at time of event - patient is 18 years or older.

• 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: 11187132
• Report Number: 2134265-2021-00431
• Device Sequence Number: 14252583
• Product Code: FGE
• UDI-Device Identifier: 08714729793939
• UDI-Public: 08714729793939
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K141521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2021

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: 06/23/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0025628357
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2021
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 55