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

Model Number UNK-P-IPP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

The ams 700 flat reservoir was visually inspected and functionally tested; no leaks were found.The reservoir therefore performed within specification.The ams700 ipp cylinders were visually inspected and functionally tested.Cylinder 1 had a leak in the proximal cylinder body that was the result of sharp instrument damage consistent with explant damage; a hole was present.Due to this damage being consistent with explant it will be considered a secondary failure.Cylinder 1 was not functionally tested due to a leak was identified.Cylinder 2 was functionally tested and performed within specification; no leak was found.The ams 700 momentary squeeze (ms) pump was visually inspected; 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.However, product analysis concluded that identified a pump failed activation test was the most probable cause of the device malfunction.Product analysis identified device malfunction with the returned pump.

Event Description

Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.No device event was provided in the device return.

Manufacturer Narrative

Duplicate to report 2183959-2020-02744.The ams 700 flat reservoir was visually inspected and functionally tested; no leaks were found.The reservoir therefore performed within specification.The ams700 ipp cylinders were visually inspected and functionally tested.Cylinder 1 had a leak in the proximal cylinder body that was the result of sharp instrument damage consistent with explant damage; a hole was present.Due to this damage being consistent with explant it will be considered a secondary failure.Cylinder 1 was not functionally tested due to a leak was identified.Cylinder 2 was functionally tested and performed within specification; no leak was found.The ams 700 momentary squeeze (ms) pump was visually inspected; 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.However, product analysis concluded that identified a pump failed activation test was the most probable cause of the device malfunction.Product analysis identified device malfunction with the returned pump.

Event Description

Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.No device event was provided in the device return.

• 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: 11135113
• MDR Text Key: 225723859
• Report Number: 2183959-2020-06303
• 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: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• 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: 12/08/2020
• Date Manufacturer Received: 02/17/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention