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

Model Number	72404239
Medical Device Problem Codes	Collapse (1099); Deflation Problem (1149); Mechanical Problem (1384); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Swelling/ Edema (4577)
Date of Event	04/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that within the first few days post-implant of this inflatable penile prosthesis, the patient experienced intense pain and tenderness in his stomach and scrotum.Additionally, the pump of the ipp did not inflate properly.The patient presented to the emergency room because he was unable to deflate his prostheses for two days following intercourse.After multiple attempts, the device was deflated.A physical exam confirmed pain, discomfort and significant swelling in the area of pump implant.The patient was seen by the physician for a follow-up appointment as the patient was unable to fully pump the implant; this resulted in pain and non-functional device.A physical examination by the physician confirmed the collapsed pump was consistent with a malfunctioning pump or leak.After allowing the swelling to subside, the patient was seen by the physician again.The physician noted that the pump had shifted, and the deflation button was now on the left side.The physician instructed the patient on the use of the pump.No further patient complications were reported.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17575100
• Report Number: 2124215-2023-44076
• Device Sequence Number: 18234644
• Product Code: FHW
• UDI-Device Identifier: 00878953003528
• UDI-Public: 00878953003528
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/18/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/14/2022
• Device Model Number: 72404239
• Device Catalogue Number: 72404239
• Device Lot Number: 1000503874
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR UPN 720185-01 LOT 1100071058
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Male