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

Model Number UNK-P-IPP

Device Problems Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616); Free or Unrestricted Flow (2945)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 02/20/2020

Event Type  malfunction  

Event Description

It was reported that patient states he had an original inflatable penile prosthesis (ipp) implant back in december.Implant is hard to inflate.Patient went to a second urologist who states device was put in wrong.The tip is not far enough forward into the head of penis and the pump bulb is to high in scrotum, making it hard to inflate.Patient will see a third urologist.Device may need to be replaced.Additional information was received.Patient visited a new urologist and physician states device may have to be replaced.

Manufacturer Narrative

G2.Report source corrected to consumer: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegations cannot be confirmed.Based on the information available, a conclusion code of no problem detected was assigned to this investigation.

Event Description

It was reported that patient states he had an original inflatable penile prosthesis (ipp) implant back in december.Implant is hard to inflate.Patient went to a second urologist who states device was put in wrong.The tip is not far enough forward into the head of penis and the pump bulb is to high in scrotum, making it hard to inflate.Patient visited a new urologist and physician states device may have to be replaced.Procedure has not been scheduled.

• 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 9826533
• MDR Text Key: 183293817
• Report Number: 2183959-2020-01256
• 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: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• 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?: No
• Date Manufacturer Received: 04/20/2022
• 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 Age: 71 YR
• Patient Sex: Male