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

Model Number UNK-P-IPP

Device Problems Inflation Problem (1310); Material Deformation (2976)

Patient Problem Scarring (2061)

Event Date 01/25/2019

Event Type  Injury  

Event Description

It was reported that the patient experienced scarring and the inflatable penile prosthesis (ipp) partially filled and was not sufficient for intercourse.During surgery, penoscrotal incision was made and pump was released from pseudocapsule.The surgeon examined the implant and found it to be working correctly.It is believed that the scarring caused a kink in the tubing.The ipp pump was repositioned and the incision was closed.No further complications were reported in relation to this event.The product was not explanted and not expected to be returned.Should additional information be received, a supplemental report will be filed.

• 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: mike bocchino ; 10700 bren road w; ,; minnetonka, MN 55343 ; 6515827161
• MDR Report Key: 8356238
• MDR Text Key: 136714778
• Report Number: 2183959-2019-60937
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 01/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR