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

Model Number	24674
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 pinhole located approximately 3mm proximal of the proximal markerband.An examination of the balloon material and proximal markerband 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 found no kinks or damage along the shaft of the device.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 23-dec-2019.It was reported that balloon leak occurred.The target lesion was located in the subglottic area.A 3.0 x 40, 135cm mustang balloon catheter was advanced for dilatation.However, when the balloon was inflated to 10 atmospheres, some liquid came out around the balloon under endoscopy.The device was removed and balloon leakage was noted.The procedure was completed with another mustang balloon catheter.There were no patient complications reported.However, returned device analysis revealed balloon pinhole.

• 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: 9577159
• Report Number: 2134265-2019-16461
• Device Sequence Number: 2902510
• Product Code: FGE
• UDI-Device Identifier: 08714729794035
• UDI-Public: 08714729794035
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K103751
• 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
• Report Date (Section B): 01/10/2020

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: 0024381729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 6 MO