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

Model Number UNK-P-IPP

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problem Hernia (2240)

Event Date 12/09/2023

Event Type  Injury  

Event Description

It was reported that the patient with this inflatable penile prosthesis (ipp), presented with a hernia as a result of reservoir migration.The ipp reservoir was explanted.During the explant procedure, the reservoir was broken due to the surgical instruments used.A new reservoir was implanted.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 patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

Manufacturer Narrative

Corrected h6 device codes and b5 describe event.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 devices as indicated in the instructions for use.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 an inflatable penile prosthesis (ipp), presented with a hernia as a result of the reservoir being out of place.The ipp reservoir was explanted.During the explant procedure, the reservoir was broken due to the surgical instruments used.A new reservoir was implanted.There were 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: 18692456
• MDR Text Key: 335186554
• Report Number: 2124215-2024-08006
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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,Followup
• Report Date: 05/08/2024

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 Model Number: UNK-P-IPP
• Device Catalogue Number: UNK-P-IPP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention; Hospitalization