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

Model Number	72401451
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent ambicor penile prosthesis (app) revision surgery since there was fluid loss though proximal part of the cylinder due to a hole.The patient outcome was reported to be fully recovered.
Additional Manufacturer Narrative
Upon receipt of the ambicor penile prosthesis (app) at our quality assurance laboratory, the returned components underwent a thorough analysis.Both cylinders were visually inspected, and the analysis determined that one of the cylinders presented a hole with broken fabric threads at the proximal end of the cylinder that resulted in a fluid leak.These abnormalities were consistent with sharp instrument damage.The other cylinder and the pump did not show signs of abnormalities or damage.Functional testing was not performed due to the leak identified in the cylinder.Based on the information available, the reported allegations could not be confirmed; therefore, a conclusion of cause not established was chosen.
Event or Problem Description
It was reported that the patient underwent ambicor penile prosthesis (app) revision surgery since there was fluid loss though proximal part of the cylinder due to a hole.The patient outcome was reported to be fully recovered.

• 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: 17445538
• Report Number: 2124215-2023-41053
• Device Sequence Number: 19465766
• Product Code: FHW
• UDI-Device Identifier: 00878953000954
• UDI-Public: 00878953000954
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted 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,Followup
• Report Date (Section B): 09/14/2023

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: 06/03/2023
• Device Model Number: 72401451
• Device Catalogue Number: 72401451
• Device Lot Number: 1000115689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2018
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown