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

Model Number	72404253-12
Medical Device Problem Codes	Fluid/Blood Leak (1250); 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	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 date of event -no event date provided; date used is approximated.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not working as expected because there was an issue with the pump and fluid refill, also there was a slight fluid loss.No additional information was reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this ipp underwent a thorough analysis.The cylinders were microscopically inspected, and leak tested.Both cylinders passed visual inspection.No damage or abnormalities were found.Both cylinders passed the leakage test.The pump was microscopically inspected, leak and functionally tested.Pump passed visual inspection.No damage or abnormalities were found.Pump passed leak test.Functional test revealed that pump failed activation tests two and three.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not working as expected because there was an issue with the pump and fluid refill, also there was a slight fluid loss.No additional information was 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: 20464720
• Report Number: 2124215-2024-64187
• Device Sequence Number: 12692430
• Product Code: FHW
• UDI-Device Identifier: 00878953009827
• UDI-Public: 00878953009827
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2024

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: 02/21/2026
• Device Model Number: 72404253-12
• Device Catalogue Number: 72404253-12
• Device Lot Number: 1100456100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 12/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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 Sex: Unknown