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

Model Number	72404283
Medical Device Problem Codes	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	03/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented with this inflatable penile prosthesis (ipp) that was not working as intended.Two weeks later, surgical intervention was performed to revise the ipp, and a tear was identified in the left cylinder.The pump and cylinders were replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt of the inflatable penile prosthesis (ipp) at our quality assurance laboratory the returned components underwent a thorough analysis.Microscopic inspection of both cylinders found wear at a fold in the middle of the cylinder.One of the cylinders had two holes resulting in a leak, in the proximal end, and consistent with sharp instrument damage.The other cylinder had a hole in the other tube with broken fabric threads from wear at the proximal end of the cylinder.This cylinder also presented a leak from input tube wear at the proximal end.The pump was inspected, and no abnormalities were identified, but the device did not pass the activation test.Based on the information, the reported observations were able to be confirmed.
Event or Problem Description
It was reported that the patient presented with this inflatable penile prosthesis (ipp) that was not working as intended.Two weeks later, surgical intervention was performed to revise the ipp, and a tear was identified in the left cylinder.The pump and cylinders were replaced.There were no patient complications 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 55311
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19169537
• Report Number: 2124215-2024-24742
• Device Sequence Number: 12750004
• Product Code: FHW
• UDI-Device Identifier: 00878953003863
• UDI-Public: 00878953003863
• 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: 2023
• 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): 08/28/2024

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: 01/03/2026
• Device Model Number: 72404283
• Device Catalogue Number: 72404283
• Device Lot Number: 1000504618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2021
• 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: LOT# 1000084759 - PUMP MS.; LOT# 1000084759 - PUMP MS.; LOT# 1000328664 - RESERVOIR FLAT 100 ML.; LOT# 1000328664 - RESERVOIR FLAT 100 ML.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male