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

Model Number 72404253-12

Device Problems Inflation Problem (1310); Failure to Deflate (4060)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2023

Event Type  Injury  

Event Description

It was reported that, six weeks after the implant procedure of this inflatable penile prosthesis (ipp), the physician noted inflation issues.A week later, the device was evaluated, and it was noted that, event it works, it is difficult to inflate and deflate it.No surgical intervention has been performed.

Event Description

It was reported that, six weeks after the implant procedure of this inflatable penile prosthesis (ipp), the physician noted inflation issues.A week later, the device was evaluated, and it was noted that, event it worked, it was difficult to inflate and deflate it.Two months later, a surgical procedure was performed to remove and replace the pump.No additional information was reported.

Manufacturer Narrative

Upon receipt at our quality assurance laboratory, the returned component underwent a thorough analysis.The pump was visually and functionally inspected, and leak tested.No visual damage or abnormalities were noted, no leaks were identified; however, the pump did not pass activation test during functional inspection.Based on the information available and analysis results, the pump not passing the activation test could have caused or contributed to the reported clinical observations.

Event Description

It was reported that, six weeks post-implant of this inflatable penile prosthesis (ipp), the device was exhibiting inflation issues which were confirmed by the physician.A week later, the device was evaluated, and it was noted that, although it was working, the ipp was difficult to inflate and deflate.A surgical procedure was performed to remove and replace the pump.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: 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: 18064313
• MDR Text Key: 327254374
• Report Number: 2124215-2023-61567
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953009827
• UDI-Public: 00878953009827
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: 72404253-12
• Device Catalogue Number: 72404253-12
• Device Lot Number: 1100195172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 01/24/2024; 02/15/2024
• Supplement Dates FDA Received: 02/13/2024; 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization