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	07/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 60% stenosed target lesion was located in an arteriovenous shunt in a mildly tortuous and non-calcified vessel.A 10.0 x 80, 135cm mustang balloon catheter was advanced for dilatation.However, during the first inflation at 7 atmospheres, the balloon ruptured.The device was completely removed from the patient and the procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 60% stenosed target lesion was located in an arteriovenous shunt in a mildly tortuous and non-calcified vessel.A 10.0 x 80, 135cm mustang balloon catheter was advanced for dilatation.However, during the first inflation at 7 atmospheres, the balloon ruptured.The device was completely removed from the patient and the procedure was completed with a different device.No patient complications were reported and the patient's status was stable.The device was returned fro analysis.A visual and microscopic examination was performed on the returned device.The device was returned trapped within the customer 6fr sheath.The balloon was unfolded which indicates it had been subjected to positive pressure.The balloon material was noted to be in two separate sections and severely bunched at both the distal and proximal end of the 6fr sheath.In order to fully evaluate the balloon material, the investigator dissected the 6fr sheath and removed the distal section from the device.A visual and microscopic examination identified a complete circumferential tear in the balloon material approximately 30mm proximal to the proximal edge of the distal markerband.No issues were noted with the balloon material that could have contributed to the complaint incident.A visual and tactile examination identified multiple kinks and stretching damage on the shaft of the device.This type of damage is consistent with excessive force being applied to the delivery system.No issues were noted with the shaft of the device that could have contributed to the complaint incident.A visual and microscopic examination identified that both markerbands were present and fully attached to the shaft.No damage or any issues were noted with the markerbands that could have contributed to the complaint incident.A visual and microscopic examination of the tip identified that the distal tip was flared.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: 7799721
• Report Number: 2134265-2018-60235
• Device Sequence Number: 1195604
• Product Code: FGE
• UDI-Device Identifier: 08714729795254
• UDI-Public: 08714729795254
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/18/2018

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: 10/10/2020
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0021244729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1