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

Model Number	72404172
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	04/27/2023
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 known risk associated with implants of these device as indicated in the instructions for use (ifu).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 this inflatable penile prosthesis (ipp) breached the cavernous wall of the patient.It was detailed that the implant is still working properly, and a revision surgery has not been scheduled yet.No additional information was provided.

• 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: 16908388
• Report Number: 2124215-2023-23124
• Device Sequence Number: 12102153
• Product Code: FHW
• UDI-Device Identifier: 00878953003269
• UDI-Public: 00878953003269
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/10/2023

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: Lay User/Patient
• Device Expiration Date: 09/09/2017
• Device Model Number: 72404172
• Device Catalogue Number: 72404172
• Device Lot Number: 102008003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2015
• 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: PUMP: UPN: 72404209 / LOT: 101445005; RESERVOIR: UPN: 72404155 / LOT: 118858001
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male