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	06/22/2023
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 crack in the cylinder connecting tube.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt of this inflatable penile prosthesis reservoir, pump, and cylinders at our quality assurance laboratory, the returned components underwent a thorough analysis.The reservoir was visually inspected, and leak tested.The reservoir had wear at a fold in reservoir shell.The reservoir passed leakage test.The pump was visually inspected, leak tested, and functionally tested.The pump passed visual inspection and there were no visual damages or abnormalities found.The pump passed the leak test.The pump failed activation tests 2 and 3.The first cylinder was visually inspected, and leak tested.This cylinder had wear at a fold in the proximal end, middle, and distal end of the cylinder.The outer tube and fabric thread tubing of this cylinder had a hole with fluid loss in the proximal end of the cylinder from kink resistant tubing (krt) wear.The second cylinder was visually inspected, leak tested, and pressure tested.This cylinder had wear at a fold in the proximal end and the middle of the cylinder.This cylinder had frayed fabric threads from an undetermined wear in the proximal end of the cylinder.This cylinder passed the leakage test and the pressure test.Based on the information available and analysis results, the reported mechanical issue was able to be confirmed and the cause was traced to a component failure.
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 crack in the cylinder connecting tube.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: 17336921
• Report Number: 2124215-2023-37563
• Device Sequence Number: 7331714
• 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: 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): 09/08/2023

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: 03/04/2018
• Device Model Number: 72404274
• Device Catalogue Number: 72404274
• Device Lot Number: 0818808003
• 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: 06/27/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2016
• 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: 153968003; PUMP: UPN: 72404310 / LOT: 153968003; RESERVOIR: UPN: 72404161 / LOT: 150022020; RESERVOIR: UPN: 72404161 / LOT: 150022020
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male