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

Model Number	72404300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Neither the reported patient symptoms or device performance allegation can be confirmed.Based on the information available, a conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that the patient underwent a surgical procedure to replace the inflatable penile prosthesis (ipp) due to pain in the surgical site.A new ipp was implanted with no clinical consequences to the patient.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes that the reported pain was unable to be confirmed through analysis.However, the device instructions for use describes various scenarios that can result in patient pain.The patient device experience is included in the labeling, therefore, anticipated in nature.Technical analysis: the pump, cylinders, and reservoir were returned for analysis to our post market quality assurance laboratory.Visual examination of the cylinders identified that there was a hole in both cylinders that commonly observed to occur during the explant procedure.The cylinders were not functionally tested due to the holes that led to fluid loss.The pump performed within all visual and functional testing parameters.The reservoir performed within all visual and functional testing parameters.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.In addition, the ifu describes various scenarios which can result in pain.Device history record: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Investigation conclusion: 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 a surgical procedure to revise this inflatable penile prosthesis (ipp) due to pain at the surgical site.The ipp was explanted and not replaced with no clinical consequences to the patient.

• Brand Name: AMS INFLATABLE 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: 12470981
• Report Number: 2124215-2021-27778
• Device Sequence Number: 19766914
• Product Code: FHW
• UDI-Device Identifier: 00878953005713
• UDI-Public: 00878953005713
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/07/2025
• Device Model Number: 72404300
• Device Catalogue Number: 72404300
• Device Lot Number: 1000376568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 10/22/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR