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

Model Number	24674
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occured.The 90% stenosed target lesion was located in a moderately tortuous vessel.A 4.0 x 20, 40cm mustang balloon catheter was advanced for dilatation.After inflation was performed, the guide wire remained and angiography was tried to perform.However, the balloon catheter could not be removed from the guide wire.The device was simply removed from the patient's body.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the customer guidewire was returned with the complaint device.The analyst had no difficulty removing the customer guidewire from the device during the analysis, the customer guidewire removed without any resistance.It was identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.It is not known when the balloon was subjected to positive pressure.An examination of the balloon material identified no issues which could potentially have contributed to this complaint.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 microscopic examination of the tip was completed.No damage or any issues were noted with the tip that could have contributed to the complaint incident.A visual and microscopic examination of the marker bands was completed.There was no burrs or uneven edges observed on the marker bands.No damage or any issues were noted with the marker bands that could have contributed to the complaint incident.No issues were identified during device analysis.
Event or Problem Description
It was reported that device entrapment occured.The 90% stenosed target lesion was located in a moderately tortuous vessel.A 4.0 x 20, 40cm mustang balloon catheter was advanced for dilatation.After inflation was performed, the guide wire remained and angiography was tried to perform.However, the balloon catheter could not be removed from the guide wire.The device was simply removed from the patient's body.The procedure was completed with a different 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: 8931995
• Report Number: 2134265-2019-09373
• Device Sequence Number: 11294746
• Product Code: FGE
• UDI-Device Identifier: 08714729794172
• UDI-Public: 08714729794172
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 09/12/2019

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: 03/06/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0023454114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Initial Date Received by Manufacturer: 07/27/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 09/12/2019
• 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: GUIDE WIRE: RADIFOCUS.; GUIDE WIRE: RADIFOCUS.; INTRODUCER SHEATH: MOSQUITO.; INTRODUCER SHEATH: MOSQUITO.; GUIDE WIRE: RADIFOCUS; INTRODUCER SHEATH: MOSQUITO