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

Model Number 72404252

Device Problems Failure to Cycle (1142); Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2020

Event Type  Injury  

Event Description

It was reported that the patient has scheduled a revision surgery for an inflatable penile prosthesis (ipp) on (b)(6) 2020 due to the device not functioning correctly.The physician suspects fluid loss because he tried to inflate/ deflate the device but the device is not cycling correctly.The device currently pumps and moves some fluid into the cylinders but creates a partial erection and then no additional fluid can be moved into the cylinders.There were no patient complications related to this device.

Event Description

It was reported that the patient has scheduled a revision surgery for an inflatable penile prosthesis(ipp) on (b)(6) 2020 due to the device not functioning correctly.The physician suspects fluid loss because he tried to inflate/deflate the device but the device is not cycling correctly.The device currently pumps and moves some fluid into the cylinders but creates a partial erection and then no additional fluid can be moved into the cylinders.There were no patient complications related to this device.

Manufacturer Narrative

The ams700 ipp cylinders were visually inspected and functionally tested.Both of cylinders had wear at folds; no leaks were found.The ams 700 momentary squeeze (ms) pump was visually inspected.The krt was worn to filament; no leaks were found.The pump was functionally tested and failed activation test.Product analysis was unable to confirm the reported event related to fluid leak; refer to tw (b)(4) in which a reservoir confirmed the fluid leak in reservoir shell.However, product analysis concluded that identified a pump failed activation test as the most probable cause the device malfunction.Product analysis confirmed a device malfunction.The ams 700 flat reservoir was visually inspected and functionally tested.There was a leak in the reservoir shell that result of wear at the corner of a fold; hole was present.Review of manufacturing documentation was performed to ensure that all required in-process and final inspections and testing were completed.Review of the manufacturing records for tcf 104814 found no evidence that the device failed to meet applicable product specifications prior to shipment from bsc.Based on this investigation, the investigation conclusion code of cause traced to component failure was chosen because the reported device allegations could be traced to a component failure.Based on the results of this investigation, no escalation is required.

Manufacturer Narrative

Additional information received that the patient had a procedure to replace the ipp device on (b)(6) 2020.A leak was found on the wall of the reservoir.Allegation related to fluid leak and mechanical issue was reported.The ams700 ipp cylinders were visually inspected and functionally tested.Both of cylinders had wear at folds; no leaks were found.The ams 700 momentary squeeze (ms) pump was visually inspected.The krt was worn to filament; no leaks were found.The pump was functionally tested and failed activation test.Product analysis was unable to confirm the reported event related to fluid leak; refer to tw#12543710 in which a reservoir confirmed the fluid leak in reservoir shell.However, product analysis concluded that identified a pump failed activation test as the most probable cause the device malfunction.Product analysis confirmed a device malfunction.The product record review indicated reported events do not represent an unanticipated event.Review of the manufacturing documentation confirmed all required in-process and final inspections and testing were completed.Based on this investigation, the investigation conclusion code of cause traced to component failure was chosen because the reported device allegations could be traced to a component failure.Based on the results of this investigation, no escalation is required.

Event Description

It was reported that the patient has scheduled a revision surgery for an inflatable penile prosthesis(ipp) on (b)(6) 2020 due to the device not functioning correctly.The physician suspects fluid loss because he tried to inflate/deflate the device but the device is not cycling correctly.The device currently pumps and moves some fluid into the cylinders but creates a partial erection and then no additional fluid can be moved into the cylinders.There were no patient complications related to this device.

• 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: 10156571
• MDR Text Key: 195224279
• Report Number: 2183959-2020-02522
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003603
• UDI-Public: 00878953003603
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/30/2017
• Device Model Number: 72404252
• Device Catalogue Number: 72404252
• Device Lot Number: 108370003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Date Manufacturer Received: 07/07/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 64 YR