MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS Inflatable Penile Prosthesis; device impotence mechanical/hydraulic

Model Number	72404283
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384)
Health Effect - Clinical Codes	Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that following the implant of this inflatable prosthesis, the patient was unable to inflate due to the hardness of the pump.The mri showed the cylinders were well positioned and there was a problem with the pump.The patient was instructed not to use the pump.A revision surgery is expected.No patient complications were reported.

• 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 ; +1(508)652-1217
• MDR Report Key: 18639468
• Report Number: 2124215-2024-06114
• Device Sequence Number: 7725710
• Product Code: FHW
• UDI-Device Identifier: 00878953003863
• UDI-Public: 00878953003863
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/29/2022
• Device Model Number: 72404283
• Device Catalogue Number: 72404283
• Device Lot Number: 0181498008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR UPN 720182-01 LOT 1000581151.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male