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

Model Number 72404251

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Insufficient Information (4580)

Event Date 10/24/2023

Event Type  Injury  

Event Description

It was reported that the patient presented with floppy glans due to incorrect sizing of this inflatable penile prosthesis (ipp).A revision surgery was performed and reimplanted the upsized ipp.There were no additional patient complications reported.

Manufacturer Narrative

There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported event could not be confirmed.Based on the analysis results, an investigation conclusion code of unintended use error caused or contributed to event was assigned to this investigation as incorrect size of the device may have caused the reported event.

Event Description

It was reported that the patient presented with floppy glans due to incorrect sizing of this inflatable penile prosthesis (ipp).A revision surgery was performed and reimplanted the upsized ipp.There were no additional 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: 18123894
• MDR Text Key: 327997569
• Report Number: 2124215-2023-63712
• Device Sequence Number: 1
• Product Code: FHW
• 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,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 72404251
• Device Catalogue Number: 72404251
• Device Lot Number: 1100171399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2022
• 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
• Treatment: REAR TIP EXTENDER: 72404321/1100051280; REAR TIP EXTENDER: 72404321/1100051280; RESERVOIR: 720185-01/1100178920; RESERVOIR: 720185-01/1100178920
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR