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

Model Number 72404161

Device Problem Migration (4003)

Patient Problem Internal Organ Perforation (1987)

Event Date 01/08/2021

Event Type  Injury  

Event Description

It was reported that the patient went to the hospital two weeks before surgery because the inflatable penile prosthesis was not working properly.The examination confirmed that the reservoir entered the bladder.The pump and reservoir components were removed, the patient was expected to have a reimplant surgery at a later date.Following the procedure, the patient was stable and the event resolved.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4089353452
• MDR Report Key: 11178859
• MDR Text Key: 227081369
• Report Number: 2183959-2021-00068
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003238
• UDI-Public: 00878953003238
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/26/2021
• Device Model Number: 72404161
• Device Catalogue Number: 72404161
• Device Lot Number: 118867007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2016
• 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: PUMP MODEL 72404310 LOT 1000425265
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR