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

Model Number	72401455
Medical Device Problem Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Adhesion(s) (1695)
Date of Event	08/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the patient underwent surgical intervention to explant the ambicor penile prosthesis (app) due to a bulge of the right cylinder and adhesion of the pump to the right testicle.A new app was implanted and there were no additional patient complications reported.
Event or Problem Description
It was reported that the patient underwent surgical intervention to explant the ambicor penile prosthesis (app) due to a bulge of the right cylinder and adhesion of the pump to the right testicle.A new app was implanted and there were no additional patient complications reported.
Additional Manufacturer Narrative
Previously, upon receipt of the device at our quality assurance laboratory, this device underwent a thorough analysis.The ambicor device was visually inspected and no leaks were found.One of the cylinders had broken fabric threads at a fold.This cylinder exhibited bulging when inflated.Both cylinders were not functionally tested due to the identified bulging.The pump performed within specifications.Based on the information available, it cannot be confirmed what the cause of the adhesion was.The reason for the reported bulge of the right cylinder was determined to be due to a bulge and broken fabric threads at a fold which were identified during functional testing of the returned components.With the additional information provided on the clinical observations of adhesions, the reported patient symptoms, as they relate to scarring, are known risk associated with implants of these device as indicated in the instructions for use (ifu).This investigation was assigned the most probable conclusion code of cause traced to component failure.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17814367
• Report Number: 2124215-2023-52373
• Device Sequence Number: 11372565
• Product Code: FHW
• UDI-Device Identifier: 00878953000992
• UDI-Public: 00878953000992
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2016
• 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): 01/03/2024

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: 10/08/2012
• Device Model Number: 72401455
• Device Catalogue Number: 72401455
• Device Lot Number: 519025009
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/31/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2007
• 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: 73 YR
• Patient Sex: Male