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

Model Number	72404256
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The first cylinder was microscopically inspected and had a hole in the distal end of the cylinder from sharp instrument.The first cylinder had wear at fold in the proximal end and middle of the cylinder.The first cylinder kink resistant tubing (krt) was worn to the filament.The first cylinder did not pass the leakage testing.The second cylinder was microscopically inspected and had wear at fold in the proximal end and middle of the cylinder.The second cylinder kink resistant tubing (krt) had a hole from wear.The second cylinder did not pass the leakage testing.The momentary squeezed (ms) pump kink resistant tubing (krt) was microscopically inspected and were worn to the filament.Krt were cut shorter for functional testing.The pump passed the leakage and functional testing.The flat reservoir was microscopically inspected and had wear at a fold in reservoir shell.The flat reservoir passed leakage test.This investigation was assigned to the conclusion code of cause traced to component failure.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not functioning.There were deflation and inflation issues.It was noted that the left cylinder was not deflating properly.The ipp was explanted and replaced.There were no patient complications.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not functioning.There were deflation and inflation issues.It was noted that the left cylinder was not deflating properly.The ipp was explanted and replaced.There were no patient complications.

• 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: 20279429
• Report Number: 2124215-2024-59091
• Device Sequence Number: 7564367
• Product Code: FHW
• UDI-Device Identifier: 00878953003641
• UDI-Public: 00878953003641
• Combination Product (Y/N): Y
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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: 07/22/2016
• Device Model Number: 72404256
• Device Catalogue Number: 72404256
• Device Lot Number: 891126002
• 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: 08/30/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2014
• 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 720185-01 / LOT 899037009; RESERVOIR: UPN 720185-01 / LOT 899037009
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male