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

Model Number	72404261
Medical Device Problem Codes	Collapse (1099); Inflation Problem (1310); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis complained of inflation issues as the implant did not get to the tip of their glans and had difficulties activating the pump, which led to an in-clinic evaluation.Pump troubleshooting was performed; however, performance issues were not resolved.It was decided to remove and replace the pump and cylinders, the new components were connected to the existing reservoir.There were no patient complications reported.
Additional Manufacturer Narrative
Additional information was received that changed the awareness date in the initial report submitted.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis complained of inflation issues as the implant did not get to the tip of their glans and had difficulties activating the pump, which led to an in-clinic evaluation.Pump troubleshooting was performed; however, performance issues were not resolved.It was decided to remove and replace the pump and cylinders, the new components were plugged in to the existing reservoir.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt, this product was thoroughly analyzed in our quality assurance laboratory.The cylinders, pump, and reservoir were visually inspected, microscopically examined, leak and functionally tested.All components performed within specification.Product analysis was unable to confirm the clinical observations.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis complained of inflation issues as the implant did not get to the tip of their glans.They had difficulties activating the pump, the patient was evaluated in-clinic.Pump troubleshooting was performed; however, the performance issues were not resolved.It was decided to remove and replace the pump and cylinders, the new components were plugged in to the existing reservoir.There were no patient complications reported.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• 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 ; 4089353452
• MDR Report Key: 14256017
• Report Number: 2124215-2022-14268
• Device Sequence Number: 20139528
• Product Code: FHW
• UDI-Device Identifier: 00878953003696
• UDI-Public: 00878953003696
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2022

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: 03/12/2023
• Device Model Number: 72404261
• Device Catalogue Number: 72404261
• Device Lot Number: 1000543373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/27/2022
• Supplement Date Received by Manufacturer: 03/21/2022; 07/22/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 05/09/2022; 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male