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

Model Number	72404274
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	02/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was seen by the physician as the inflatable penile prosthesis did not work as expected.Two weeks later, the patient had the inflatable penile prosthesis replaced due to a tear in the cylinder.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt of the cylinders, pump, and reservoir of this inflatable penile prosthesis (ipp) at our quality assurance laboratory, the returned components underwent a thorough analysis.All components were visually inspected, and leak tested.The first cylinder had a leak in the inner tube and the outer tube was detached with broken fabric threads at the bonding joint that was the result of sharp instrument damage consistent with explant.The second cylinder was worn at a fold in the middle of the cylinder body.No leaks were found.The ms (momentary squeeze) pump had no visual abnormalities noted.No leaks were found.During functional testing, the pump did not pass activation testing.The flat reservoir had no visual abnormalities noted.No leaks were found.Based on the information available and analysis results.The reported clinical event of a tear in the cylinder was not confirmed; however, the pump issues found during analysis could have impacted device function as reported clinically.
Event or Problem Description
It was reported that the patient was seen by the physician as the inflatable penile prosthesis did not work as expected.Two weeks later, the patient had the inflatable penile prosthesis replaced due to a tear in the cylinder.No patient complications were 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16414434
• Report Number: 2124215-2023-08066
• Device Sequence Number: 3365253
• Product Code: FHW
• UDI-Device Identifier: 00878953003818
• UDI-Public: 00878953003818
• 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: 2023
• 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): 04/27/2023

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: 02/27/2022
• Device Model Number: 72404274
• Device Catalogue Number: 72404274
• Device Lot Number: 0165098005
• 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: 02/07/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2017
• 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: CYLINDERS UPN: 72404274 LOT#: 165098005; PUMP UPN: 72404310 LOT#: 1000084759; PUMP UPN: 72404310 LOT#: 1000084759; RESERVOIR UPN: 720182-01 LOT# 1000047697
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male