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	04/03/2020
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 moderately calcified artery.A 8.0 x 100, 75cm mustang balloon catheter was advanced for dilatation.However, during first inflation at 14 atmospheres for 30 seconds, the balloon ruptured.The device was removed without any issues.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
(e1) initial reporter address 1: (b)(6).(e1) initial reporter city: (b)(6).Device evaluated by mfr.: mustang was received 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 proximal balloon sleeve and extending approximately 32mm distally across the balloon material.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic 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 visual and tactile examination identified no issues or damage to the tip of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified artery.A 8.0 x 100, 75cm mustang balloon catheter was advanced for dilatation.However, during first inflation at 14 atmospheres for 30 seconds, the balloon ruptured.The device was removed without any issues.The procedure was completed with another of the same device.No patient complications were 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: 9950551
• Report Number: 2134265-2020-04962
• Device Sequence Number: 3272283
• Product Code: FGE
• UDI-Device Identifier: 08714729793700
• UDI-Public: 08714729793700
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/07/2020

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: 01/22/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0025092208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2020
• Initial Date Received by Manufacturer: 04/03/2020
• Supplement Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 05/07/2020
• 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: RADIFOCUS 35.; GUIDEWIRE: RADIFOCUS 35.; INFLATION DEVICE: FUJI MEDICAL INDEFLATOR.; INFLATION DEVICE: FUJI MEDICAL INDEFLATOR.; INTRODUCER SHEATH: TERUMO 5FRR.; INTRODUCER SHEATH: TERUMO 5FRR.