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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
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 crack in the cylinder connecting tube was found.The device was 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 crack in the cylinder connecting tube was found.The device was 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 wear at a fold in the proximal end and distal end of the cylinder.The first cylinder had two holes with a leak at both corners of a fold in the proximal end of the cylinder.The second cylinder had wear at a fold in the proximal end and distal end.The second cylinder kink resistant tubing (krt) had a hole with a leak from sharp instrument damage.The momentary squeeze (ms) pump was microscopically inspected.And the ms pump krts were worn to the filament.The pump did not pass the activation tests.The ms pump passed leak test.The reservoir was microscopically inspected and had wear at a fold in reservoir shell.The reservoir passed leak test.This investigation was assigned a most probable 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: 19557768
• Report Number: 2124215-2024-36975
• Device Sequence Number: 14636096
• 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: 2018
• 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): 09/09/2024

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: 04/10/2022
• Device Model Number: 72404272
• Device Catalogue Number: 72404272
• Device Lot Number: 0171491007
• 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: 05/29/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2017
• 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: 72404161 LOT#: 0184123019 RESERVOIR; UPN: 72404161 LOT#: 0184123019 RESERVOIR; UPN: 72404310 LOT#: 0182651002 PUMP; UPN: 72404310 LOT#: 0182651002 PUMP
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male