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

Model Number	72404230
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had the inflatable penile prosthesis was removed due to malfunction.A new inflatable penile prosthesis was implanted.The patient was stable following the procedure.
Event or Problem Description
It was reported that the patient had the inflatable penile prosthesis was removed due to malfunction.After the initial implant surgery, the doctor ordered the patient a period of 5 to 6 weeks of postoperative rest before starting to use the device.After this period the patient communicated to the physician that the prosthesis did not work correctly.The doctor verified that even if the pump operated, it would not completely fill and the prosthesis would not work properly.During replacement surgery the components were checked, and a loss of fluid was observed at the connection of the pump to the cylinders.The reservoir was found to be ok, and since it was only a few months old, the doctor decided to keep it and to change all the other components.A new inflatable penile prosthesis cylinder and pump components were implanted.The patient was stable following the procedure.
Additional Manufacturer Narrative
Device evaluation the ams700 ipp cylinders were visually inspected and functionally tested.Cylinder 1 performed with specification; no leak was found.Cylinder 2 has a large leak in the input tube sleeve which connecting to the cylinder.A large hole was present.This hole/damage was the result of sharp instrument damage.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.Product analysis confirmed fluid leak in the connection of the pump to the cylinder.Product analysis therefore identified a pump failed activation as the most probable cause of the mechanical issue.
Event or Problem Description
It was reported that the patient had the inflatable penile prosthesis was removed due to malfunction.After the initial implant surgery, the doctor ordered the patient a period of 5 to 6 weeks of postoperative rest before starting to use the device.After this period the patient communicated to the physician that the prosthesis did not work correctly.The doctor verified that even if the pump operated, it would not completely fill and the prosthesis would not work properly.During replacement surgery the components were checked, and a loss of fluid was observed at the connection of the pump to the cylinders.The reservoir was found to be ok, and since it was only a few months old, the doctor decided to keep it and to change all the other components.A new inflatable penile prosthesis cylinder and pump components were implanted.The patient was stable following the procedure.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 10231260
• Report Number: 2183959-2020-02809
• Device Sequence Number: 3093340
• Product Code: FHW
• UDI-Device Identifier: 00878953003436
• UDI-Public: 00878953003436
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/06/2020
• Device Model Number: 72404230
• Device Catalogue Number: 72404230
• Device Lot Number: 1000158872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 07/11/2020; 08/10/2020
• Initial Report FDA Received Date: 07/05/2020
• Supplement Report FDA Received Date: 08/07/2020; 08/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR