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

Model Number	72401452
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Defective Device (2588); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this ambicor penile prosthesis (app) right cylinder was not inflating.The cylinder was worn, a fluid leak was identified, and air was present in the system, which made it unable to properly pump.The app was explanted and replaced.There were no patient complications reported.

• Brand Name: AMS AMBICOR
• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20579129
• Report Number: 2124215-2024-68420
• Device Sequence Number: 20889651
• Product Code: FHW
• UDI-Device Identifier: 00878953000961
• UDI-Public: 00878953000961
• 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: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/31/2024

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: 04/13/2021
• Device Model Number: 72401452
• Device Catalogue Number: 72401452
• Device Lot Number: 0130860002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 10/31/2024
• 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 Age: 68 YR
• Patient Sex: Unknown