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

Model Number	72404236
Medical Device Problem Codes	Deflation Problem (1149); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) exhibited deflation issues; therefore, a surgical procedure was performed to remove and replace all the components.There were no patient complications reported.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) exhibited deflation issues; therefore, a surgical procedure was performed to remove and replace all the components.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.Both cylinders were microscopically inspected and tested for leaks.The first cylinder exhibited wear at folds in the middle and distal end of its body, and additionally, its kink resistant tubing (krt) presented a hole and a leak consistent with sharp instrument damage.A hole in the proximal end of the second cylinder was also noted; however, it was consistent with sharp instrument damage and the component passed the leakage examination.The pump was microscopically inspected, leak and functionally tested.It was noted that its krt was worn to the filament.No leaks were identified, and the pump passed the functional evaluation.The reservoir was microscopically inspected and tested for leaks.Wear at fold in its shell was noted, but no leaks were identified.Based on the information available and analysis results, the reported clinical observation of deflation issues could not be confirmed.

• 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: 20344247
• Report Number: 2124215-2024-61116
• Device Sequence Number: 8000100
• Product Code: FHW
• UDI-Device Identifier: 00878953003498
• UDI-Public: 00878953003498
• 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: 2022
• 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): 11/25/2024

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: 11/13/2023
• Device Model Number: 72404236
• Device Catalogue Number: 72404236
• Device Lot Number: 1100047563
• 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: 09/12/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2021
• 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: 1100099146; RESERVOIR: UPN: 720185-01 / LOT: 1100099146
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown