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

Model Number	72404273
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	05/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis was not working properly.Two weeks later, a surgical procedure was performed, during which a tear in both cylinders was noted.All components were removed and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned components underwent a thorough analysis.Both cylinders were microscopically inspected and tested for leaks.The first cylinder exhibited wear at fold in the middle, proximal and distal end of its body, along with a hole in the outer tube of its proximal end.In addition, the kink resistant tubing (krt) was worn to the filament.The second cylinder presented, wear at fold in the middle and proximal end of its body, along with broken fabric threads and a hole in its proximal end.In addition, the krt was worn to the filament.None of the cylinders passed the leakage evaluation.The pump was microscopically inspected, leak and functionally tested.No damage or abnormalities were noted upon microscopic evaluation, and no leaks were identified; however, the component did not pass activation test during functional examination.The reservoir was microscopically inspected and tested for leaks.Microscopic evaluation revealed that the component had wear at fold in its shell, and additionally, the krt was worn to the filament.No leaks were identified in the reservoir.Based on the information available and analysis results, the hole and fluid leak identified in each cylinder, along with the pump not passing the functional inspection, could have caused or contributed to the reported clinical observations.
Event or Problem Description
It was reported that this inflatable penile prosthesis was not working properly.Two weeks later, a surgical procedure was performed, during which a tear in both cylinders was noted.All components were removed and 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: 19458901
• Report Number: 2124215-2024-33768
• Device Sequence Number: 6812251
• Product Code: FHW
• UDI-Device Identifier: 00878953003801
• UDI-Public: 00878953003801
• 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: 2018
• 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): 08/23/2024

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: 01/24/2023
• Device Model Number: 72404273
• Device Catalogue Number: 72404273
• Device Lot Number: 1000039319
• 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: 05/20/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2018
• 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: UPN: 72404310 / LOT: 1000071531; PUMP: UPN: 72404310 / LOT: 1000071531; RESERVOIR: UPN: 72404161 / LOT: 1000090632; RESERVOIR: UPN: 72404161 / LOT: 1000090632
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male