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

Model Number UNK-P-IPP

Device Problems Collapse (1099); Deflation Problem (1149); Inflation Problem (1310); Mechanical Problem (1384)

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

Event Date 12/14/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent an inflatable penile prosthesis (ipp) procedure due to the pump was sticky and never worked.The pump was removed and replaced.No patient complications were reported in relation to this event.

Event Description

It was reported that the patient underwent an inflatable penile prosthesis (ipp) procedure due to the pump was sticky and never worked after a month being implanted.The pump was removed and replaced.No patient complications were reported in relation to this event.

Manufacturer Narrative

The complaint component was returned and analyzed, and the reported allegation was confirmed via product analysis.The ams 700 momentary squeeze (ms) pump was visually inspected and functionally tested; no leaks were found.The pump was functionally tested and failed the 8lb.Activation test.The pump therefore required more than 8lbs.Of force to activate.Product analysis concluded these activation issues could affect the functionality of the pump.Based on this investigation, the investigation conclusion code of cause traced to component failure was chosen because the reported events could be traced to a component failure.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.

• 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
• MDR Report Key: 11098168
• MDR Text Key: 224511601
• Report Number: 2183959-2020-06195
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Date Manufacturer Received: 01/08/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR