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

Model Number	72404267
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Related component of device system: model number/ catalog number: 720185-01.Serial number: n/a.Batch/ lot number: 1000138354.Model/ catalog description: reservoir flat iz 100 ml.
Event or Problem Description
It was reported that the patient experienced unspecified issues with an inflatable penile prosthesis (ipp).The device was removed and a new ipp was implanted.No patient complications were reported in relation to this event.No more information is available at the moment, additional information was requested and will be provided as it becomes available.Additional information received.The device was replaced due to it stopped working, the specific issue is unknown.There were no patient adverse effects and patient is doing fine.The implant procedure of the previous device was on (b)(6) 2018.
Additional Manufacturer Narrative
The complaint component was returned and analyzed, and the reported allegation was confirmed via product analysis.Malfunction was reported.The ams700 device was visually inspected and functionally tested.No leak was found.The cylinders performed within specifications.The pump failed the inflation test and did not transfer a sufficient amount of fluid to fully inflate the cylinders.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.Related component of device system: model number/ catalog number: 720185-01 serial number: n/a batch/ lot number: 1000138354 model/ catalog description: reservoir flat iz 100 ml.
Event or Problem Description
It was reported that the patient experienced unspecified issues with an inflatable penile prosthesis (ipp).The device was removed and a new ipp was implanted.No patient complications were reported in relation to this event.No more information is available at the moment, additional information was requested and will be provided as it becomes available.Additional information received.The device was replaced due to it stopped working, the specific issue is unknown.There were no patient adverse effects and patient is doing fine.The implant procedure of the previous device was on (b)(6) 2018.

• 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: 8798438
• Report Number: 2183959-2019-65068
• Device Sequence Number: 11532890
• Product Code: FHW
• UDI-Device Identifier: 00878953003757
• UDI-Public: 00878953003757
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

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: 07/11/2020
• Device Model Number: 72404267
• Device Catalogue Number: 72404267
• Device Lot Number: 1000132427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/26/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR