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

Model Number	72404268
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the pump of this inflatable penile prosthesis (ipp) was not working properly; therefore, a revision surgery was performed to remove and replace cylinders and pump.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned components underwent a thorough analysis.Both cylinders were microscopically inspected and tested for leaks.The first cylinder exhibited wear at fold in the proximal end of its body, along with a hole in its middle, consistent with sharp instrument damage, resulting in a leak.The second cylinder presented wear at fold in the proximal end of its body, but no leaks were identified.The pump was microscopically inspected, leak and functionally tested.No damage or abnormalities were noted during microscopic evaluation, and no leaks were identified.However, the pump did not pass activation test upon functional examination.Based on the information available and analysis results, the pump not passing functional inspection could have caused or contributed to the reported clinical observation of the device not working properly.
Event or Problem Description
It was reported that the pump of this inflatable penile prosthesis (ipp) was not working properly; therefore, a revision surgery was performed to remove and replace cylinders and pump.There were no patient complications 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19613733
• Report Number: 2124215-2024-39173
• Device Sequence Number: 7097215
• Product Code: FHW
• UDI-Device Identifier: 00878953003764
• UDI-Public: 00878953003764
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2024

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: 11/07/2024
• Device Model Number: 72404268
• Device Catalogue Number: 72404268
• Device Lot Number: 1100212381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown