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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient went to the hospital because this inflatable penile prosthesis (ipp) was not working properly.Two weeks later, a revision surgery was performed, during which a crack in the connecting tube of the cylinder was identified.The cylinder and the pump 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.Cylinder 1 was visually inspected, and leakage tested.Visual inspection revealed holes in the middle of its body caused by a sharp instrument; consequently, the cylinder presented a fluid leak.Cylinder 2 was visually inspected, leakage tested, and pressure tested.During visual examination it was noted that there was a hole and broken fabric threads in the middle of the cylinder body, both caused by a sharp instrument.Cylinder 2 passed leakage and pressure tests.The pump was visually and microscopically inspected and tested for leaks.Microscope observation identified bodily fluid contamination within the pump; therefore, the components was not functionally tested.Based on the information available and analysis results, the reported clinical observation of a crack in the connecting tube of the cylinder could not be confirmed.A conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the patient went to the hospital because this inflatable penile prosthesis (ipp) was not working properly.Two weeks later, a revision surgery was performed, during which a crack in the connecting tube of the cylinder was identified.The cylinder and the pump 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17647525
• Report Number: 2124215-2023-46723
• Device Sequence Number: 12340704
• 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: 2022
• Device Explanted Year: 2023
• 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): 10/03/2023

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: 06/11/2026
• Device Model Number: 72404293
• Device Catalogue Number: 72404293
• Device Lot Number: 1000579497
• 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: 08/10/2023
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2021
• 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: (B)(6)/ LOT: 1000586370; PUMP: UPN:(B)(6)/ LOT: 1000586370; RESERVOIR: UPN: (B)(6) / LOT: 1000263114; RESERVOIR: UPN: (B)(6)/ LOT: 1000263114
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male