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	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 4.0 x 40, 135cm mustang balloon catheter was advanced for predilaton.However, during inflation at 8 atmospheres, the balloon ruptured.The balloon was removed and dilatation was performed using a 4mm balloon.Following deployment of a 7.0 x 80 eluvia drug-eluting stent, post-dilatation was performed with a 6.0 x 40, 135cm mustang balloon catheter.However, during inflation at 4 atmospheres, the balloon ruptured.The procedure was completed with a different device.There were no patient complications nor injuries reported.

• 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: 11279768
• Report Number: 2134265-2021-01270
• Device Sequence Number: 2689033
• Product Code: FGE
• UDI-Device Identifier: 08714729793557
• UDI-Public: 08714729793557
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2021

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: 03/28/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0023565445
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE USED: RADIFOCUS35; INTRODUCER SHEATH USED: DESTINATION 6; STENT USED: ELUVIA 7-80