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

Model Number	72401453
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation summary: based on the information available, the cause that contributed to the reported mechanical issue cannot be confirmed as the product is not available for analysis.Device history record: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could not be performed.Investigation conclusion: based on the information available, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the patient underwent a surgical procedure to revise this ambicor penile prosthesis (app) due to deflation issues.The app was explanted and replaced with a new app with no clinical consequences to the patient.

• 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
• MDR Report Key: 12234524
• Report Number: 2124215-2021-21498
• Device Sequence Number: 19808423
• Product Code: FHW
• UDI-Device Identifier: 00878953000978
• UDI-Public: 00878953000978
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• 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): 07/27/2021

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: 08/13/2019
• Device Model Number: 72401453
• Device Catalogue Number: 72401453
• Device Lot Number: 895161005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 07/27/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR