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

Model Number 72404155

Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310); Material Puncture/Hole (1504); Difficult or Delayed Activation (2577); Air/Gas in Device (4062)

Patient Problem Scar Tissue (2060)

Event Date 07/25/2023

Event Type  Injury  

Manufacturer Narrative

The implant date and lot numbers were unable to be obtained through good faith efforts.The data was obtained through a review of the surgical history previously provided by the physician.

Event Description

It was reported that this inflatable penile prosthesis (ipp) exhibited inflation issues and a fluid leak; it was suspected there was a hole in the reservoir.A revision procedure was performed and significant scarring in patients scrotum and corpora was discovered.The device was explanted and replaced.No patient complications were reported in relation to this event.

• 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17538176
• MDR Text Key: 321038610
• Report Number: 2124215-2023-42252
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003207
• UDI-Public: 00878953003207
• 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: 08/13/2023

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/22/2015
• Device Model Number: 72404155
• Device Catalogue Number: 72404155
• Device Lot Number: 827212004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2013
• 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: CX PRECONNECT: UPN: 72404231 / LOT: 816254004
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Race: White