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

Model Number 72404013

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Unspecified Infection (1930); Pain (1994)

Event Date 02/27/2023

Event Type  Injury  

Manufacturer Narrative

There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these device as indicated in the instructions for use (ifu).Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

Event Description

It was reported that the patient with this inflatable penile prosthesis (ipp) experienced penile infection and pain in addition with an ulcerated - infected fistula at the base of the scrotum.The patient was treated with antibiotics and a removal surgery was performed.Nine months later, a reimplant surgery was performed.There were no device issues and no additional patient complications reported.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• 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: 18363514
• MDR Text Key: 330985738
• Report Number: 2124215-2023-72433
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953002705
• UDI-Public: 00878953002705
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 72404013
• Device Catalogue Number: 72404013
• Device Lot Number: 1000394200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2020
• 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: UPN: 72404310 / LOT: 1000509316; RESERVOIR: UPN: 72404161 / LOT: 1000336091
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 75 KG