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	02/06/2024
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 inflatable penile prosthesis cylinder and pump were removed and replaced due to a tear in the right cylinder.No patient complications were reported.
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 inflatable penile prosthesis cylinder and pump were removed and replaced due to a tear in the right cylinder.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt of this inflatable penile prosthesis (ipp) at our quality assurance laboratory, the returned components underwent a thorough analysis.The first cylinder had a leak at the corner of a fold in the middle of the cylinder.This cylinder had a leak from a sharp instrument in the proximal end of the cylinder.Under a microscope, this cylinder had wear at a fold in the middle of the cylinder.This cylinder had wear at a fold in the proximal end of the cylinder.This cylinder had a hole at the corner of a fold in the middle of the cylinder.This cylinder had a hole in the proximal end of the cylinder.Under a microscope, the second cylinder had wear at a fold in the middle of the cylinder.This cylinder had wear at a fold in the proximal end of the cylinder.The pump had trimmed kink resistant tubing (krt) with the window quick connect (wqc) with damaged tubing prior functional testing.The pump did not pass inflation test 1.The pump did not pass activation testing.The pump had a leak at the pump strain relief junction from a sharp instrument.Under a microscope, the pump krt was worn to the filament.The pump had a hole at the pump strain relief junction from a sharp instrument.Based on the information available and analysis results, the mechanical issue and cylinder tear were confirmed, and the cause was 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: 18757228
• Report Number: 2124215-2024-10523
• Device Sequence Number: 11688215
• 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: 2017
• 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): 04/09/2024

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: 02/21/2022
• Device Model Number: 72404272
• Device Catalogue Number: 72404272
• Device Lot Number: 0165093003
• 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: 02/06/2024
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2017
• 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: PUMP UPN 72404310 LOT 175684006; PUMP UPN 72404310 LOT 175684006; RESERVOIR UPN 72404161 LOT 173608016; RESERVOIR UPN 72404161 LOT 173608016
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male