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

Model Number	72401458
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930)
Date of Event	12/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the returned ambicor cylinder, pump, and tubing were visually inspected.There was no damage to the cylinder or pump.A portion of the pump of the pump strain relief kink resistant tubing (krt) was found to be closed or plugged with the screw.Review of manufacturing documentation confirm all required in-process and final inspections and testing were completed.There was no evidence that the device did not meet applicable product specifications prior to shipment from boston scientific.The product record review found the reported events do not represent an unanticipated event.Analysis was unable to confirm the reported pain and infection.
Event or Problem Description
It was reported that the patient underwent a surgical procedure to explant this ambicor penile prosthesis (app) device due to infection secondary to erosion of the ventral glans of the penis.It was noted only one cylinder was implanted as the patient is transgender.No further patient complications were reported.

• 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: 11323911
• Report Number: 2183959-2021-00419
• Device Sequence Number: 19874367
• Product Code: FHW
• UDI-Device Identifier: 00878953001029
• UDI-Public: 00878953001029
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2021

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: 04/16/2024
• Device Model Number: 72401458
• Device Catalogue Number: 72401458
• Device Lot Number: 1000263144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 02/12/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 47 YR