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

Model Number	72401453
Medical Device Problem Codes	Deflation Problem (1149); Degraded (1153); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation summary: based on the information available, boston scientific concludes that the cause that contributed to the reported event cannot be established as the product is not available for analysis.Device history record review: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.However, there are several failure modes of the device that could lead to bulge, deflation and mechanical issue, which include but are not limited to a device or component issues that could lead to an aneurysm in the cylinder causing bulges or deflation issue in the device.Without a returned product available for analysis and based on this investigation a clear probable cause for the event cannot be established.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.There is no objective evidence that the user did not properly handle or use the device according to the ambicor instructions for use (ifu).The ambicor ifu lists altered therapeutic response as a potential adverse event associated with implant of this device.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 remove this ambicor penile prosthesis (app) system in which an aneurysm in the left cylinder had stopped the device from deflating.It was replaced by an inflatable penile prosthesis (ipp) system.There were no patient complications 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
• MDR Report Key: 12447555
• Report Number: 2124215-2021-26951
• Device Sequence Number: 19745739
• Product Code: FHW
• UDI-Device Identifier: 00878953000978
• UDI-Public: 00878953000978
• 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: 2013
• 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): 09/09/2021

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: 11/08/2010
• Device Model Number: 72401453
• Device Catalogue Number: 72401453
• Device Lot Number: 433448001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR