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

Model Number	72404234
Medical Device Problem Codes	Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) replacement surgery due to both cylinders ruptured.All components were removed and replaced with new ones.There were no patient complications reported.
Event or Problem Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) replacement surgery due to both cylinders ruptured.All components were removed and replaced with new ones.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The reservoir, cylinders and pump were visually and microscopically examined, and leak tested; the cylinders were also pressure tested and the pump was functionally tested.No anomalies were found with the reservoir.One of the cylinders had broken fabric threads and a bulging in the inner tubing with a hole.The other cylinder passed all testing.The pump did not pass the functional testing as it did not pass the inflation and activation tests based on the information available and analysis results, the bulging and hole identified in the cylinder could have caused or contributed to the reported clinical observation of hole/perforated.Also, the functional anomalies identified in the pump could affect the proper functionality of the device.

• 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
• MDR Report Key: 15692471
• Report Number: 2124215-2022-44243
• Device Sequence Number: 7360016
• Product Code: FHW
• UDI-Device Identifier: 00878953003474
• UDI-Public: 00878953003474
• 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 Implanted Year: 2022
• 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
• Report Date (Section B): 01/06/2023

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: 12/15/2019
• Device Model Number: 72404234
• Device Catalogue Number: 72404234
• Device Lot Number: 1000022890
• 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: 06/29/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2017
• 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: 889617005; RESERVOIR:UPN: 720185-01 LOT: 889617005
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown