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

Model Number	72404230
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a replacement surgery to re-implant an ams 700 inflatable penile prosthesis (ipp) due to fluid loss.There were no patient complications.No further information provided.
Additional Manufacturer Narrative
Corrected d4.Model number and catalog number.
Event or Problem Description
It was reported that the patient had a replacement surgery to re-implant an ams 700 inflatable penile prosthesis (ipp) due to fluid loss.There were no reported complications with the patient.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The cylinders and pump were visually and microscopically examined, and leak/functionally tested.Cylinder one outer tubing had a hole found by the proximal end, a leak as the result of fatigue in the inner tube was found when the cylinder was inflated.No anomalies were found with cylinder two.No anomalies were found with the pump on the visual inspection, but the component did not pass the activation test.The reservoir was returned and visually and microscopically examined, and leak/functionally tested.The analysis of the reservoir did not find any anomalies as the reservoir performed as expected.Based on the information available and analysis results, the leak found in the cylinder one could have caused or contributed to the reported clinical observation of fluid leak.
Event or Problem Description
It was reported that the patient had a replacement surgery to re-implant an ams 700 inflatable penile prosthesis (ipp) due to fluid loss.There were no reported complications with the patient.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• 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: 14347848
• Report Number: 2124215-2022-15958
• Device Sequence Number: 14472457
• Product Code: FHW
• UDI-Device Identifier: 00878953003436
• UDI-Public: 00878953003436
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 01/03/2023

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: 04/17/2014
• Device Model Number: 72404230
• Device Catalogue Number: 72404230
• Device Lot Number: 768785004
• 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: 04/29/2022
• Supplement Date Received by Manufacturer: 10/21/2022; 12/20/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 10/31/2022; 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2011
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR: UPN 720185-01/LOT 754328020
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown