MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG; CATHETER, BILIARY, DIAGNOSTIC

Model Number	24673
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occured.A 7.0 x 200, 75cm mustang balloon catheter was advanced for dilation.However, during the initial inflation at 6 atmospheres, the balloon ruptured.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: 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.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon longitudinal tear beginning approximately 50mm proximal of the distal markerband and extending approximately 3mm 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 observed no issues with the tip of the device which could potentially have contributed to the complaint incident.A visual and tactile examination found the shaft of the device to be kinked at approximately 330mm distal of the strain relief.This type of damage is consistent with excessive force being applied to the delivery system.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occured.A 7.0 x 200, 75cm mustang balloon catheter was advanced for dilation.However, during the initial inflation at 6 atmospheres, the balloon ruptured.No patient complications nor injuries were reported.It was further reported that the target lesion was located in the heavily calcified superficial femoral artery.

• 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: 8325148
• Report Number: 2134265-2019-01031
• Device Sequence Number: 16177901
• Product Code: LIT
• UDI-Device Identifier: 08714729794189
• UDI-Public: 08714729794189
• Combination Product (Y/N): N
• PMA/510(K) Number: K103751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2019

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: 10/09/2021
• Device Model Number: 24673
• Device Catalogue Number: 24673
• Device Lot Number: 0022771726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1