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

Model Number	72404268
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, although the pump of this inflatable penile prosthesis pump was still functional, it was slightly sticky, placed too high in the scrotum, and undersized.The pump and cylinders were explanted and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt of this inflatable penile prosthesis (ipp) at our quality assurance laboratory, the returned components underwent a thorough analysis.The pump was functionally tested and performed within specification.Both cylinders were visually inspected, and leak tested.The kink resistant tubing (krt) was worn to the filament.The first cylinder had a leak from tool/sharp instrument in the middle of the cylinder body.The second cylinder was visually inspected, and leak tested.No leaks were found.Based on the information available and analysis results, the clinical events could not be confirmed.
Event or Problem Description
It was reported that, although the pump of this inflatable penile prosthesis pump was still functional, it was slightly sticky, placed too high in the scrotum, and undersized.The pump and cylinders were explanted and replaced.No patient complications were 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16768868
• Report Number: 2124215-2023-18540
• Device Sequence Number: 17741927
• Product Code: FHW
• UDI-Device Identifier: 00878953003764
• UDI-Public: 00878953003764
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/11/2020
• Device Model Number: 72404268
• Device Catalogue Number: 72404268
• Device Lot Number: 1000119182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male