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

Model Number	72404267
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Erosion (1750); Perforation (2001)
Date of Event	01/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a week prior to the surgery the right cylinder of an inflatable penile prosthesis (ipp) eroded into the urethra.The patient was on honeymoon and indicated using the device "a great deal of the time".During the procedure the tip of the implant was visible eroding through the right side of the urethra.There were no signs of infection.The physician cut and removed the cylinder and then secured the remaining tubing with a metal plug.No other components were explanted.The patient did not experience further adverse events and was said to be good after the procedure.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 9744102
• Report Number: 2183959-2020-00795
• Device Sequence Number: 13903874
• Product Code: FHW
• UDI-Device Identifier: 00878953003757
• UDI-Public: 00878953003757
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2020

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: 04/24/2019
• Device Model Number: 72404267
• Device Catalogue Number: 72404267
• Device Lot Number: 0172921003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 02/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 45 YR