MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS AMBICOR PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC

Model Number	72401454
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	10/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient had the ambicor penile prosthesis removed due to edema and pain.No further patient complications were reported.
Event or Problem Description
It was reported the patient had the ambicor penile prosthesis removed due to edema and pain.No further patient complications were reported.
Event or Problem Description
It was reported the patient had the ambicor penile prosthesis removed due to edema and pain.No further patient complications were reported.
Additional Manufacturer Narrative
Investigation summary: based on the information available, the cause that contributed to the reported pain and edema could not be established as the product is not available for analysis.Device history record review (dhr): the device history record review (dhr) confirmed that the device met all material, assembly and performance specifications.A risk review confirmed that the event is accounted for in the risk documentation.Device technical analysis: the device was not available for analysis; therefore, no physical or visual analysis of the product could be performed.Labeling review: a review of the device instructions for use (ifu) was completed and did not review any evidence of device off-label use or failure to follow instructions.Investigation conclusion: based on this investigation and all information available, a conclusion code of known inherent risk of device was assigned to this investigation.Risk review and labeling review identified that the adverse event of edema and pain are a known risk of the device.The allegation of edema and pain are unable to be confirmed due to the lack of a product return to analyze.However, there are several failure modes of the device that could lead to edema and pain, which include but are not limited to a device malfunction or defective components.Without a returned product available for analysis and based on this investigation a clear probable cause for the event cannot be established; therefore, the conclusion code of known inherent risk of device has been chosen.

• Brand Name: AMS AMBICOR PENILE PROSTHESIS
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 13588242
• Report Number: 2124215-2022-05567
• Device Sequence Number: 17597162
• Product Code: FHW
• UDI-Device Identifier: 00878953000985
• UDI-Public: 00878953000985
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2022

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: Lay User/Patient
• Device Expiration Date: 05/10/2021
• Device Model Number: 72401454
• Device Catalogue Number: 72401454
• Device Lot Number: 0135506005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 03/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Unknown