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

Model Number	72404011
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	06/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) stopped working as intended.Two weeks later, surgical intervention took place to revise the device, and a hole was found in the right cylinder.The pump and right cylinder 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 component underwent a thorough analysis.The cylinder was microscopically inspected and found fold in the proximal end, the middle, and the distal end.At the proximal end, a hole and broken fabric threads were also identified.The cylinder did not pass the leak test.Based on the information available, the reported allegations were confirmed.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) stopped working as intended.Two weeks later, surgical intervention took place to revise the device, and a hole was found in the right cylinder.The pump and right cylinder 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 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19860607
• Report Number: 2124215-2024-46946
• Device Sequence Number: 8160311
• Product Code: FHW
• UDI-Device Identifier: 00878953002682
• UDI-Public: 00878953002682
• 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: 2024
• 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): 10/04/2024

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 Model Number: 72404011
• Device Catalogue Number: 72404011
• Device Lot Number: 1100280332
• 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: 07/09/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UPN: 72401110 LOT: 794240001 - PUMP; UPN: 72401110 LOT: 794240001 - PUMP
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male