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); Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2020

Event Type  Injury  

Manufacturer Narrative

Based on the investigation, the device was not returned for analysis and there were no ncprs associated with the product return for this specific complaint.This investigation is considered as a no product return.As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint.The reported allegations could not be confirmed.The event cannot be reproduced or sustained; therefore, no escalation to ncep, cpa, or scar is required.

Event Description

It was reported that the patient underwent a surgical procedure to revise this inflatable penile prosthesis (ipp) due to the pump being stuck and is no longer able to use the device that started within a week of becoming aware of the event.The ipp cylinder, pump, and reservoir was explanted and replaced with a new ipp cylinder, pump, and reservoir.

• 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: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4089353452
• MDR Report Key: 11112625
• MDR Text Key: 225035140
• Report Number: 2183959-2020-06240
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2021

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: 12/11/2020
• Initial Date FDA Received: 01/04/2021
• 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
• Patient Age: 73 YR