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

Model Number	72404267
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the preparation of an inflatable penile prosthesis (ipp) implant surgery, the medical staff compressed the pump bulb several times to inflate the cylinders, and when they pushed and held the deflate button, nothing happened.After several attempts, they had to squeeze the sides of the pump block; this works, but when cycling, the original deflate button has the same issue.The physician cycles the implant again and ran into the same issue.Also, it was noticed that the pump filled much slower than it should.A different device was used to complete the procedure instead, with no patient complications.
Event or Problem Description
It was reported that during the preparation of an inflatable penile prosthesis (ipp) implant surgery, the medical staff compressed the pump bulb several times to inflate the cylinders, and when they pushed and held the deflate button, nothing happened.After several attempts, they had to squeeze the sides of the pump block; this works, but when cycling, the original deflate button has the same issue.The physician cycles the implant again and ran into the same issue.Also, it was noticed that the pump filled much slower than it should.A different device was used to complete the procedure instead, with no patient complications.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the pump and cylinders of this inflatable penile prosthesis (ipp) underwent a thorough analysis.The pump was microscopically inspected, leak and functionality tested.The pump passed visual inspection, no damage or abnormalities were found.The pump passed both the leak and functional tests.The cylinders were microscopically inspected and leak tested.Both cylinders passed visual inspection, no damage or abnormalities were found.Both cylinders passed the leak test.Based on the information available, a conclusion code of no problem detected was assigned to this investigation.

• 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: 20502078
• Report Number: 2124215-2024-64158
• Device Sequence Number: 8488311
• Product Code: FHW
• UDI-Device Identifier: 00878953003757
• UDI-Public: 00878953003757
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 11/25/2024

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: Lay User/Patient
• Device Expiration Date: 09/28/2025
• Device Model Number: 72404267
• Device Catalogue Number: 72404267
• Device Lot Number: 1100369117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/30/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2023
• 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: Other
• Patient Age: 53 YR
• Patient Sex: Male