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

Model Number	72404011
Medical Device Problem Codes	Collapse (1099); 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	05/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not working as intended.The pump would remain dimpled when squeezed.Surgical intervention was performed to replace the pump and cylinders.There were no patient complications reported.
Additional Manufacturer Narrative
Correction made to a1 patient identifier and a2 date of birth upon receipt of the inflatable penile prosthesis (ipp) at our quality assurance laboratory the returned components underwent a thorough analysis.Microscopic examination found both cylinders had wear at a fold in the middle of the cylinder body.They both passed leak testing.Inspection of the pump identified no abnormalities and passed the leak and functional testing.Based on the available information, the reported observations were unable to be confirmed.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not working as intended.The pump would remain dimpled when squeezed.Surgical intervention was performed to replace the pump and cylinders.There were no patient complications reported.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• 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: 19355502
• Report Number: 2124215-2024-30084
• Device Sequence Number: 18061806
• Product Code: FHW
• UDI-Device Identifier: 00878953002682
• UDI-Public: 00878953002682
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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: 05/09/2026
• Device Model Number: 72404011
• Device Catalogue Number: 72404011
• Device Lot Number: 1000563020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2021
• 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: PUMP: UPN: 72404310 LOT#: 100080997; PUMP: UPN: 72404310 LOT#: 100080997
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male