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

Model Number	72401453
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had the ambicor penile prosthesis removed as the rigidity had changed so that it did not remain rigid over time.A new 14mm x 18cm ams ambicor penile prosthesis was implanted.
Event or Problem Description
It was reported that the patient had the ambicor penile prosthesis removed as the rigidity had changed so that it did not remain rigid over time.A new 14mm x 18cm ams ambicor penile prosthesis was implanted.Additional information received indicated the device would lose its rigidity over a couple minutes, fluid would not stay in the cylinders.

• Brand Name: AMS AMBICOR PENILE PROSTHESIS
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 8052998
• Report Number: 2183959-2018-60802
• Device Sequence Number: 11131156
• Product Code: FHW
• UDI-Device Identifier: 00878953000978
• UDI-Public: 00878953000978
• 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
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2019

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: 07/23/2014
• Device Model Number: 72401453
• Device Catalogue Number: 72401453
• Device Lot Number: 605269002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 04/19/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR