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

Model Number	72404283-12
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation for the implant procedure of an inflatable penile prosthesis, when pressing the pump deflation button, air would not release from the cylinders.The technician attempted to deflate by squeezing the sides of the pump block to manipulate the deflation valve, holding the deflating button, releasing and squeezing the pump, alternating back and forth.However, the issue persisted.The cylinders were filled with saline and fluid would not release after pressing the deflation button.The physician squeezed the implant as hard as he could and the implant finally deflated.When inflated again, the deflation issue persisted.Therefore, another device was opened to complete the procedure.There were no patient complications.
Event or Problem Description
It was reported that during preparation for the implant procedure of an inflatable penile prosthesis, when pressing the pump deflation button, air would not release from the cylinders.The technician attempted to deflate by squeezing the sides of the pump block to manipulate the deflation valve, holding the deflating button, releasing and squeezing the pump, alternating back and forth.However, the issue persisted.The cylinders were filled with saline and fluid would not release after pressing the deflation button.The physician squeezed the implant as hard as he could and the implant finally deflated.When inflated again, the deflation issue persisted.Therefore, another device was opened to complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis underwent a thorough analysis.The cylinders were visually and microscopically examined, and leak tested.No anomalies were found with the cylinders.The pump was visually and microscopically examined, leak and functionally tested.No anomalies were found with the pump.Therefore, the reported allegation was not confirmed.Based on analysis results, a conclusion code of no problem detected was assigned to this investigation.

• 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: 20136051
• Report Number: 2124215-2024-55197
• Device Sequence Number: 15273375
• Product Code: FHW
• UDI-Device Identifier: 00878953009841
• UDI-Public: 00878953009841
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2026
• Device Model Number: 72404283-12
• Device Catalogue Number: 72404283-12
• Device Lot Number: 1000544236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2021
• 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
• Patient Age: 62 YR
• Patient Sex: Male