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

Model Number	72404268
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that inflatable penile prosthesis (ipp) pump malfunctioned six months after implant.The device was impossible to inflate.Patient underwent a surgical procedure to explant his ipp device.All components were explanted and replaced.
Additional Manufacturer Narrative
The complaint component was returned and analyzed, and the reported allegations of inflation issue and mechanical issue were confirmed via product analysis.The ams700 ipp cylinders were visually inspected and functionally tested; no leaks were found.The cylinders were pressure tested and performed within specification.The krt of both cylinders were worn to filament.The ams 700 momentary squeeze (ms) pump was visually inspected.The kink resistant tubing (krt) was worn to the filament; however, no leaks were present.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 reported event.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 or Problem Description
It was reported that inflatable penile prosthesis (ipp) pump malfunctioned six months after implant.The device was impossible to inflate.Patient underwent a surgical procedure to explant his ipp device.All components were explanted and replaced.

• 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: 11089998
• Report Number: 2183959-2020-06154
• Device Sequence Number: 3260593
• Product Code: FHW
• UDI-Device Identifier: 00878953003764
• UDI-Public: 00878953003764
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

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: 10/07/2021
• Device Model Number: 72404268
• Device Catalogue Number: 72404268
• Device Lot Number: 1000341382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 03/02/2021
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0427-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention