MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DISPOSABLE FURLOW TOOL; PENILE IMPLANT SURGICAL ACCESSORIES

Model Number	UNK-P-DISPOSABLE_FURLOW_TOOL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	05/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient enrolled in the it matters study and was implanted with this ambicor penile prosthesis (app) on (b)(6) 2024.Twenty six days post implant, the patient presented with hematoma in front of the pump.The physician suspected that the hematoma was a result of the furlow insertion tool.There has been no surgical intervention and no additional patient complications were reported.
Additional Manufacturer Narrative
Correction to d1 brand name, d2a common device name, d2b pro code (product code), d4 model number, d4 catalog number, d4 unique identifier, d6a implant date, d5 operator of device, h6 impact codes.
Event or Problem Description
It was reported that the patient enrolled in the it matters study and was implanted with this ambicor penile prosthesis (app) on (b)(6) 2024.Twenty six days post implant, the patient presented with hematoma in front of the pump.The physician suspected that the hematoma was a result of the furlow insertion tool.There has been no surgical intervention and no additional patient complications were reported.
Additional Manufacturer Narrative
Additional information provided to update b5 describe event/problem.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient enrolled in the it matters study and was implanted with this ambicor penile prosthesis (app) on (b)(6) 2024.Twenty-six days post implant, the patient presented with hematoma in front of the pump.The physician suspected that the hematoma was a result of the furlow insertion tool.There has been no surgical intervention and no additional patient complications were reported.The hematoma was resolved on (b)(6) 2024.

• Brand Name: DISPOSABLE FURLOW TOOL
• Common Device Name: PENILE IMPLANT SURGICAL ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19701415
• Report Number: 2124215-2024-41924
• Device Sequence Number: 16843464
• Product Code: QGA
• UDI-Device Identifier: 00878953000992
• UDI-Public: 00878953000992
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2025
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: UNK-P-DISPOSABLE_FURLOW_TOOL
• Device Catalogue Number: UNK-P-DISPOSABLE_FURLOW_TOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 07/24/2024; 05/09/2025
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 08/14/2024; 05/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Male