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

Model Number 72404232-10

Device Problems Deflation Problem (1149); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2020

Event Type  malfunction  

Event Description

It was reported that a new inflatable penile prosthesis (ipp) device was implanted.During procedure, surrogate reservoir was performed and the device inflated properly.However, it would not deflate 9 out of 10 times.At this point, the physician changed out the pump and attached a new pump to these implanted cylinders.It is believed that something with the lockout malfunctioned.The procedure was successfully completed with a new pump with no adverse patient effects.

Manufacturer Narrative

The complaint component was returned and analyzed, and the reported allegations of deflation problem and mechanical problem were 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 deflation test (1, 2, 3) and failed the 8lb.Activation test (2).The pump therefore required more than 8lbs.Of force to activate.Product analysis concluded these deflation and 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.Based on the results of this investigation, no escalation is required.

Event Description

It was reported that a new inflatable penile prosthesis (ipp) device was implanted.During procedure, surrogate reservoir was performed and the device inflated properly.However, it would not deflate 9 out of 10 times.At this point, the physician changed out the pump and attached a new pump to these implanted cylinders.It is believed that something with the lockout malfunctioned.The procedure was successfully completed with a new pump with no adverse patient effects.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 11150822
• MDR Text Key: 226223994
• Report Number: 2183959-2020-06355
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953009780
• UDI-Public: 00878953009780
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/10/2022
• Device Model Number: 72404232-10
• Device Catalogue Number: 72404232-10
• Device Lot Number: 1000469527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 01/20/2021
• Supplement Dates FDA Received: 01/22/2021
• Patient Sequence Number: 1
• Patient Age: 69 YR