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	11/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified iliac artery.A 8.0 x 20, 75cm mustang balloon catheter was advanced for dilation.However, during first inflation at 20 atmospheres for 10 seconds, the balloon ruptured.The device was completely removed and the procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified iliac artery.A 8.0 x 20, 75cm mustang balloon catheter was advanced for dilation.However, during first inflation at 20 atmospheres for 10 seconds, the balloon ruptured.The device was completely removed and the procedure was completed with another of the same device.There were no patient complications reported.It was further reported that an 8.0 x 40, 75cm mustang balloon catheter was used first and when the balloon ruptured, an 8.0 x 20, 75cm mustang balloon catheter was used but it ruptured as well.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified iliac artery.A 8.0 x 20, 75cm mustang balloon catheter was advanced for dilation.However, during first inflation at 20 atmospheres for 10 seconds, the balloon ruptured.The device was completely removed and the procedure was completed with another of the same device.There were no patient complications reported.It was further reported that an 8.0 x 40, 75cm mustang balloon catheter was used first and when the balloon ruptured, an 8.0 x 20, 75cm mustang balloon catheter was used but it ruptured as well.
Additional Manufacturer Narrative
(b)(6).The device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and inflation lumen which is evidence of a device leak.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 5mm distal to the distal end of the proximal markerband.An examination of the balloon material and markerbands 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 identified a kink on the shaft of the device at approximately 145mm distal of the strain relief.This type of damage is consistent with excessive force being applied to the device.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: 9415777
• Report Number: 2134265-2019-14721
• Device Sequence Number: 1671888
• Product Code: FGE
• UDI-Device Identifier: 08714729793519
• UDI-Public: 08714729793519
• 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,Followup
• Report Date (Section B): 01/09/2020

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 Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0022668148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 12/03/2019; 12/23/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 12/17/2019; 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1