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

Model Number	72401850
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	06/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced erosion with their inflatable penile prosthesis (ipp) control pump and that the pump was exposed.The component was removed and a procedure was scheduled to implant a new pump on a future date.There were no additional patient complications reported.
Additional Manufacturer Narrative
Based on the information available, there was no device available for analysis and there was no report of a device performance allegation during treatment.The reported patient symptom is a known risk associated with inflatable penile prosthesis (ipp) procedures and is noted as such in the device instructions for use.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on this investigation and all information available, a conclusion code of known inherent risk of device was assigned to this investigation.Risk review and labeling review identified that the adverse event of erosion is a known risk of the device.The cause of the erosion was not established by physician, although erosion is included in the labeling documentation as an adverse event of implant surgical procedure.The risks, benefits, and potential adverse events of all available treatment options should be discussed with the patient and considered by the physician and patient when choosing a treatment option is included in the document, therefore a conclusion code of known inherent risk of device was chosen.
Event or Problem Description
It was reported that the patient experienced erosion with their inflatable penile prosthesis (ipp) control pump and that the pump was exposed.The component was removed and a procedure was scheduled to implant a new pump on a future date.There were no additional patient complications reported.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS ACCESSORY KIT
• 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: 14757098
• Report Number: 2124215-2022-21898
• Device Sequence Number: 20371842
• Product Code: FHW
• UDI-Device Identifier: 00878953001135
• UDI-Public: 00878953001135
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/28/2017
• Device Model Number: 72401850
• Device Catalogue Number: 72401850
• Device Lot Number: 804499017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2012
• 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: Hospitalization; Required Intervention
• Patient Sex: Male