MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CHARGER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24683
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient developed thrombotic occlusion of the popliteal and anterior tibial arteries.This 6.0 x200, 135cm charger balloon was selected for use in a chronic total occlusion (cto) superficial femoral artery (sfa) atherectomy procedure.The cto was crossed using a zipwire and rubicon catheter.The zipwire was removed, then a thruway guidewire was pass through the rubicon.The rubicon was removed, then the jetstream catheter was utilized.One pass of the jetstream was used with blades down in a slow manner by the physician.It was removed and exchanged for a 6x200 charger balloon.A couple of inflations were performed, followed by an arteriogram, which revealed slow flow and occlusion at the popliteal artery.An export catheter was used to remove the thrombus/debris.The device would not pass; therefore, a sterling balloon was used to dilate the distal popliteal.The balloon was removed, and the export catheter was reinserted.Multiple passes were performed, removing small pieces of thrombus/debris.Some flow was restored to the popliteal and peroneal artery, with a clot at the anterior tibial (at) artery.A zipwire was used along with a bernstein catheter to access the at, then a 4x40 charger balloon was used on the at.Another arteriogram was performed revealing little to no flow to either three distal vessels.The patient was hospitalized and then taken to the operating room where open thrombectomy of the popliteal and tibial arteries, and femoral-tibial and tibial-pedal bypass grafting were performed.Additionally, the patient later received an above the knee amputation.No further patient complications were reported.

• Brand Name: CHARGER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16589853
• Report Number: 2124215-2023-12538
• Device Sequence Number: 14783886
• Product Code: LIT
• UDI-Device Identifier: 08714729804369
• UDI-Public: 08714729804369
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K112697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/05/2025
• Device Model Number: 24683
• Device Catalogue Number: 24683
• Device Lot Number: 0030089358
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Race: White