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

Model Number	72401454
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the ambicor penile prosthesis (app) cylinders were not functional.Right side inflated all the time and fails to deflate, left side deflated all the time and unable to inflate.A surgical procedure was performed in which the app was removed and replaced with a tactra.During the procedure, it was noticed that the color of the fluid inside the device has changed to light brown and the smell was not normal.The device failed to deflate after removal.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt of this ambicor penile prosthesis (app) at our quality assurance laboratory, the returned device underwent a thorough analysis.The cylinders were visually examined and microscopically tested.Both components had wear at fold in the proximal end.One of the cylinders had holes in the middle of the body and the proximal end consistent with explant damage.The pump was visually examined and functionally tested.Analysis of the pump identified the component performed within specifications.During the investigation the functional test was not performed due to the holes found in the cylinder from sharp instruments.Based on the information available and analysis results, the product analysis was not able to identify the cause that could have contributed to the reported clinical observation of deflation and inflation issues.
Event or Problem Description
It was reported that the ambicor penile prosthesis (app) cylinders were not functional.Right side inflated all the time and fails to deflate, left side deflated all the time and unable to inflate.A surgical procedure was performed in which the app was removed and replaced with a tactra.During the procedure, it was noticed that the color of the fluid inside the device has changed to light brown and the smell was not normal.The device failed to deflate after removal.No patient complications were reported.

• 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: 17124487
• Report Number: 2124215-2023-30510
• Device Sequence Number: 12621147
• Product Code: FHW
• UDI-Device Identifier: 00878953000985
• UDI-Public: 00878953000985
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 09/08/2023

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: 06/08/2024
• Device Model Number: 72401454
• Device Catalogue Number: 72401454
• Device Lot Number: 1000288283
• 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: 05/15/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male