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

Model Number 72404250

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384); Material Puncture/Hole (1504); Inadequacy of Device Shape and/or Size (1583); Defective Device (2588)

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

Event Date 03/05/2024

Event Type  Injury  

Event Description

It was reported that this inflatable penile prosthesis stopped working as the patient could not pump the device.A surgical procedure was performed, during which fluid loss caused by a hole in the cylinder tubing was identified.In addition, it was noted that the implant was significantly smaller than what was measured.All components were removed and replaced.There were no patient complications reported.

• 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: 18966234
• MDR Text Key: 338431893
• Report Number: 2124215-2024-17017
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003580
• UDI-Public: 00878953003580
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2016
• Device Model Number: 72404250
• Device Catalogue Number: 72404250
• Device Lot Number: 891899002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2014
• 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
• Treatment: RESERVOIR: UPN: 72404155 / LOT: 906108002
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male