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

Model Number	72401450
Medical Device Problem Codes	Contamination (1120); Inflation Problem (1310); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation summary: based on the information available, the cause that contributed to the reported device mechanical issues related to inflation and the presence of foreign material in the device cannot be established as the product is not available for analysis.Device history record (dhr): 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.Labeling review: a review of the ambicor instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.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 experienced mechanical issues with this ambicor penile prosthesis (app) related with device inflation due to stiff and difficult to manipulate pump.A surgical procedure was performed, in which the physician started by troubleshooting the device while patient was under anesthesia, however, the issues persisted.All components of the existing app were explanted and replaced with a new app.Upon inspection of the explanted device, tissue was found inside the pump.The physician considers that this foreign material could have entered the system in a previous surgery, when one of the cylinders was replaced.No additional information was 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: 12315284
• Report Number: 2124215-2021-24358
• Device Sequence Number: 17246237
• Product Code: FHW
• UDI-Device Identifier: 00878953000947
• UDI-Public: 00878953000947
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 08/12/2021

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: Health Professional
• Device Expiration Date: 11/16/2024
• Device Model Number: 72401450
• Device Catalogue Number: 72401450
• Device Lot Number: 1000359226
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/12/2021
• 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