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

Model Number	72404293
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	01/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not working properly.Two weeks later a revision surgery was performed, upon examination a tear in the left cylinder was found.The device was explanted and replaced with a malleable device per patient's request, and the reservoir remained implanted.No patient complications were reported.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not working properly.Two weeks later a revision surgery was performed, upon examination a tear in the left cylinder was found.The device was explanted and replaced with a malleable device per patient's request, and the reservoir remained implanted.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.Both cylinders were visually inspected and underwent leak testing.Both cylinders window quick connector had damage and the kink resistant tubing (krt) was worn to the filament.Both cylinders had wear at a fold in the middle and proximal end, and fluid leakage due to a hole in the proximal end consistent with sharp instrument damage was found in the proximal end of both cylinders.The first cylinder had broken fabric threads consistent with sharp instrument damage.In addition, the first cylinder had holes and tool marks in the middle outer layer consistent with sharp instrument damage.The pump was visually inspected and underwent leak and functional testing.The pump kink resistant tubing (krt) was worn to the filament, and bodily fluid was found within the pump for which it could not be functionally tested; however, the pump passed leak testing.Analysis could not confirm the reported clinical observations; therefore, a conclusion code of cause not established was assigned to this investigation.

• 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: 18659822
• Report Number: 2124215-2024-06667
• Device Sequence Number: 20848905
• Product Code: FHW
• UDI-Device Identifier: 00878953003955
• UDI-Public: 00878953003955
• 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: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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: 07/28/2025
• Device Model Number: 72404293
• Device Catalogue Number: 72404293
• Device Lot Number: 1000438920
• 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: 04/11/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2020
• 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: 1000552053; PUMP: UPN: 72404310 / LOT: 1000552053
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male