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

Model Number	72401454
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a surgical procedure to explant an ambicor penile prosthesis (app) due to the pump remaining deflated.During the procedure, it was found that there was no fluid present in the pump.A new app was implanted.There were no patient complications reported and the patient was fine post procedure.
Event or Problem Description
It was reported that the patient underwent a surgical procedure to explant an ambicor penile prosthesis (app) due to the pump remaining deflated.During the procedure, it was found that there was no fluid present in the pump.A new app was implanted.There were no patient complications reported and the patient was fine post procedure.
Additional Manufacturer Narrative
Based on the information available, boston scientific concludes the reported dimpled/deflated pump to be the likely result of fluid loss.Upon receipt at our post market quality assurance laboratory, the ambicor penile prosthesis (app) was visually and microscopically inspected and functionally tested.Both cylinders exhibited wear at folds in the cylinder bodies.One cylinder had a leak and bulge with broken fabric threads when inflated; a hole at the corner of a fold was present.The other cylinder exhibited a bulge and broken fabric threads but no hole was present.Product analysis concluded that the identified fluid leak could affect functionality of the device as the reported inflation issue; analysis confirmed the reported observation.

• 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 14079531
• Report Number: 2124215-2022-10577
• Device Sequence Number: 20219594
• Product Code: FHW
• UDI-Device Identifier: 00878953000985
• UDI-Public: 00878953000985
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2022

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: 03/19/2017
• Device Model Number: 72401454
• Device Catalogue Number: 72401454
• Device Lot Number: 762423001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2012
• 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 Sex: Unknown