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

Model Number	72404280
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: the exact event date is unknown.The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the patient presented with inoperability of the inflatable penile prosthesis (ipp).The physician assessed the device and the cylinders did not fill after compressing the pump.The device was evaluated through an ultrasound an a full reservoir was observed.Therefore, the physician determined that a mechanical failure is the most probable cause of the issue.There were no patient complications.

• 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
• MDR Report Key: 12648936
• Report Number: 2124215-2021-31362
• Device Sequence Number: 13813740
• Product Code: FHW
• UDI-Device Identifier: 00878953003832
• UDI-Public: 00878953003832
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/18/2021

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: Lay User/Patient
• Device Expiration Date: 05/23/2018
• Device Model Number: 72404280
• Device Catalogue Number: 72404280
• Device Lot Number: 831660002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIRUPN: 720182-01LOT: UNKNOWN
• Patient Age: 79 YR