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

Catalog Number 72404231

Device Problem Material Perforation (2205)

Patient Problem Unspecified Infection (1930)

Event Date 03/15/2018

Event Type  Injury  

Manufacturer Narrative

Reservoir: lot #: 1000018617, catalog #: 720185-01, expiration date: 12/11/2019, serial #: (b)(4).

Event Description

It was reported that the patient experienced an infection following an inflatable penile prosthesis (ipp) procedure and ipp device perforation was noted.On (b)(6) 2018, during the implantation of the ipp ¿the physician sutured the foley catheter in by mistake when he closed the corporal bodies.Because of that, the patient developed an infection." on (b)(6) 2018, the ipp and foley catheter were explanted.The foley catheter was ¿removed easily after the sutures were removed from the original corporal closure¿.The cylinder was found to have been punctured during the original surgery.The physician ¿washed all compartments¿, and a new ipp was implanted.No further patient complications were reported in relation to this event.Patient status is reported as doing ¿fine¿.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 7400321
• MDR Text Key: 104528686
• Report Number: 2183959-2018-00039
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003443
• UDI-Public: 00878953003443
• Combination Product (y/n): N
• 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
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/19/2018
• Device Catalogue Number: 72404231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 53 YR