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

Model Number 72404233-12

Device Problem Malposition of Device (2616)

Patient Problems Abscess (1690); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994)

Event Date 03/18/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced pain, bleeding, abscess and infection about one month after an inflatable penile prosthesis (ipp) placement.Also, it was said that the cylinders are not positioned properly.The pain and infection were treated, but no revision has been scheduled for the device.There were no additional patient complications reported.

Manufacturer Narrative

The complaint component has not been returned; therefore, no physical or visual analysis of the product could be performed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.The clinical observations of infection, abscess, blood loss, and pain are listed as potential adverse events in product labeling.

Event Description

It was reported that the patient experienced pain, bleeding, abscess and infection approximately one month post-implant of this inflatable penile prosthesis (ipp).Also, it was reported that the cylinders were not positioned properly.The pain and infection were treated, but no revision has been scheduled for the device.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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 14882455
• MDR Text Key: 295116254
• Report Number: 2124215-2022-23776
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953009797
• UDI-Public: 00878953009797
• 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: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/14/2024
• Device Model Number: 72404233-12
• Device Catalogue Number: 72404233-12
• Device Lot Number: 1100069041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2022
• 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: RESERVOIR:UPN: 720185-01LOT: 1100041879; RESERVOIR:UPN: 720185-01LOT: 1100041879
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male