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

Model Number	72404268
Medical Device Problem Codes	Degraded (1153); Inflation Problem (1310); Mechanical Problem (1384); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, used the first date of the aware month.
Event or Problem Description
It was reported that the inflatable penile prosthesis (ipp) device had performance issues four years after implant.It had inflation issues and the pump was not operating as expected.All components were explanted without patient complications.Upon explant, it was identified that the reason for the device not functioning, as an aneurysm at the right cylinder.The pump and cylinders were explanted and replaced.The reservoir remains in service.

• 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
• MDR Report Key: 11746469
• Report Number: 2124215-2021-10701
• Device Sequence Number: 4357397
• Product Code: FHW
• UDI-Device Identifier: 00878953003764
• UDI-Public: 00878953003764
• Combination Product (Y/N): Y
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2021

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: 01/17/2016
• Device Model Number: 72404268
• Device Catalogue Number: 72404268
• Device Lot Number: 865859005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 04/29/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 50 YR