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

Model Number	72404291
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was seen by the physician as the inflatable penile prosthesis did not work as expected.Two weeks later, the inflatable penile prosthesis was removed and replaced due to a hole in the cylinder.The old reservoir remains in situ but not in use.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt of this inflatable penile prosthesis (ipp) at our quality assurance laboratory, the components underwent a thorough analysis.Under a microscope, the first cylinder had wear, a hole and a leak at a fold in the proximal end of the cylinder.Under a microscope, the second cylinder had wear at a fold in the proximal end of the cylinder.This cylinder passed the leak test.Under a microscope, the pump tubing was cut down to the pump block and the tubing was not returned for analysis.The pump did not pass activation testing.Based on the information available and analysis results, the reported hole in the tubing were unable to be confirmed but the device mechanical issue was confirmed.Therefore, the conclusion code of cause traced to component failure has been chosen.
Event or Problem Description
It was reported that the patient was seen by the physician as the inflatable penile prosthesis did not work as expected.Two weeks later, the inflatable penile prosthesis was removed and replaced due to a hole in the cylinder.The old reservoir remains in situ but not in use.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
• MDR Report Key: 18694351
• Report Number: 2124215-2024-07999
• Device Sequence Number: 17959817
• Product Code: FHW
• UDI-Device Identifier: 00878953003931
• UDI-Public: 00878953003931
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2024

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: 12/20/2017
• Device Model Number: 72404291
• Device Catalogue Number: 72404291
• Device Lot Number: 806365005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/25/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2012
• 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: PUMP UPN 72404310 LOT 1100190636; PUMP UPN 72404310 LOT 1100190636; RESERVOIR UPN 72404161 LOT 886892018; RESERVOIR UPN 72404161 LOT 886892018
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male