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

Model Number	72401450
Medical Device Problem Codes	Inflation Problem (1310); Inadequacy of Device Shape and/or Size (1583); Defective Device (2588)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Depression (2361)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an ambicor penile prosthesis (app) was implanted, the patient experienced great frustration and dissatisfaction with the results leading to discomfort and depression.The patient indicated the app was inadvertently inflating causing embarrassment and pain.Additionally, the patient noted valve resistance when trying to inflate the device; these inflation difficulties also led to pain during activation.The patient alleged the distance between the cylinders and pump was too short; therefore, the app needed to be activated in the upper part of the scrotum making the process more difficult.The patient indicated there was a big portion of the rigid, palpable parts in the corpora and when the device was deflated, the patient could not achieve sufficient concealment of the app.A surgical procedure was requested to address the experience.There were no further patient complications.

• Brand Name: AMS AMBICOR PENILE PROSTHESIS
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17717343
• Report Number: 2124215-2023-48883
• Device Sequence Number: 12567511
• Product Code: FHW
• UDI-Device Identifier: 00878953000947
• UDI-Public: 00878953000947
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2023

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: 01/13/2024
• Device Model Number: 72401450
• Device Catalogue Number: 72401450
• Device Lot Number: 1000214485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Unknown