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

Model Number	72404235
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product analysis confirmed a pump malfunction that was unrelated to the reported events.The ipp was visually inspected and functionally tested.No leak was found.Cylinders performed within specifications.Pump failed the inflation test, 8 lb.Activation test, and deflation test.Analysis concluded a pump malfunction.Product analysis did not confirm a product malfunction regarding rear tip extenders.Based on the results of this investigation, no escalation is required.No more information available at the moment.Should additional information become available, it will be provided.
Event or Problem Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) revision surgery in which a rear tip extender (rte) and a preconnected pump and cylinders were tried but not used due to unknown reason.The previous implant was explanted and a new ipp was implanted.The patient is recovering.Explanted device will be returned.No more information is available at the moment, additional information was requested and will be provided as relevant information becomes available.Additional information received.The device was tried but not implanted due to size and approach changed during surgery.The cylinder would not fit properly.It was further reported that nothing was explanted, just tried but not implanted.

• 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: 9563696
• Report Number: 2183959-2019-68557
• Device Sequence Number: 2196819
• Product Code: FHW
• UDI-Device Identifier: 00878953003481
• UDI-Public: 00878953003481
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/08/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/22/2020
• Device Model Number: 72404235
• Device Catalogue Number: 72404235
• Device Lot Number: 1000093759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 01/08/2020
• Patient Sequence Number: 1
• Patient Age: 61 YR