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

Model Number 72404252

Device Problem Migration (4003)

Patient Problems Perforation (2001); Unspecified Kidney or Urinary Problem (4503)

Event Date 08/01/2022

Event Type  Injury  

Event Description

It was reported that the patient feels that the left cylinder of his penile prosthesis has migrated into the urethra causing urination issues, because the patient feels that the rear tip extenders (rtes) are outside the corpora.In addition, the patient feels that his device could be possibly damaged due to ph from internal drainage from a lymphocele and alcohol that was introduced into drain.The patient is looking for a specialist.A boston scientific representative assisted the patient with his request.The patient will follow up with a physician.

Manufacturer Narrative

Date of event: the exact event date is unknown.

• 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 15418645
• MDR Text Key: 299865254
• Report Number: 2124215-2022-35762
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003603
• UDI-Public: 00878953003603
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/27/2017
• Device Model Number: 72404252
• Device Catalogue Number: 72404252
• Device Lot Number: 933569003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2015
• 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: RESERVOIRUPN: 720185-01LOT: 931911016
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Male