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

Model Number	72404272
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not performing as expected.Two weeks later a revision surgery was performed, upon examination a hole in the right cylinder was found.The pump and cylinders were explanted and replaced.No patient complications were reported.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not performing as expected.Two weeks later a revision surgery was performed, upon examination a hole in the right cylinder was found.The pump and cylinders were explanted and replaced.No patient complications were reported.
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 at corner of a fold in the proximal end of the cylinder and broken fabric threads from wear in the proximal end of the cylinder.The cylinder also showed wear at folds in the middle of the cylinder.This cylinder did not pass the leakage testing.The second cylinder was microscopically inspected and had wear at fold in the proximal end, middle, and distal end of the cylinder, but the cylinder passed the leak test.The momentary squeeze (ms) pump was microscopically inspected and was cut down to the pump block; the tubing was returned attached to the cylinders.The ms pump passed leak testing and functional testing.This investigation was assigned to the conclusion code of cause traced to component failure.

• 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: 20047140
• Report Number: 2124215-2024-52301
• Device Sequence Number: 18135516
• Product Code: FHW
• UDI-Device Identifier: 00878953003795
• UDI-Public: 00878953003795
• 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: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,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: 08/15/2023
• Device Model Number: 72404272
• Device Catalogue Number: 72404272
• Device Lot Number: 1000146732
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2018
• 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: LOT: 1000430661 UPN: 72404310.; PUMP: LOT: 1000430661 UPN: 72404310.; RTE: LOT: 165125068 UPN: 72404330.; RTE: LOT: 165125068 UPN: 72404330.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male