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

Model Number	72404291
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	12/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient went to the hospital due to the inflatable penile prosthesis (ipp) not working properly.Two weeks later, a replacement surgery was performed.Upon explant, a crack was identified in the right cylinder connecting tube; however, the cause of the hole was not detailed by the facility.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt of the inflatable penile prosthesis (ipp) at our quality assurance laboratory, the returned components underwent a thorough analysis.Visual examination of the cylinders found a leak in one of the cylinders that was consistent with sharp instrument damage.The other cylinder did not present any leaks and was performing within product specifications.Examination of the reservoir did not find any abnormalities or leaks.The pump was inspected with no signs of leaks; however, the component did not pass the activation testing performed.Based on the information available, the reported allegations were unable to be confirmed.Due to the pump not performing within product specifications, it was concluded that the cause was traced to component failure.
Event or Problem Description
It was reported that the patient went to the hospital due to the inflatable penile prosthesis (ipp) not working properly.Two weeks later, a replacement surgery was performed.Upon explant, a crack was identified in the right cylinder connecting tube; however, the cause of the hole was not detailed by the facility.There were no patient complications.

• 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16242410
• Report Number: 2124215-2023-02844
• Device Sequence Number: 6562405
• Product Code: FHW
• UDI-Device Identifier: 00878953003931
• UDI-Public: 00878953003931
• 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: 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): 03/17/2023

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: 05/05/2020
• Device Model Number: 72404291
• Device Catalogue Number: 72404291
• Device Lot Number: 0935755005
• 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: 01/06/2023
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2015
• 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: 72404310/169055009; PUMP: 72404310/169055009; RESERVOIR: 72404161/165632006; RESERVOIR: 72404161/165632006
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male