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

Model Number	72404303
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384); Connection Problem (2900); Migration (4003)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	12/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the inflatable penile prosthesis stopped working.The patient experienced discomfort due to the device not working.The physician reports that apparently there was a leak of fluid in the reservoir which resulted in the inability to inflate the prosthesis.The physician noted that the tube connecting the pump to the reservoir was most likely disconnected.When he checked the patient, he felt the deflated reservoir outside the inguinal ring and stated that, due to the suspected fluid leak, the reservoir had likely migrated through the inguinal ring.
Additional Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.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 inflatable penile prosthesis stopped working.The patient experienced discomfort due to the device not working.The physician reports that apparently there was a leak of fluid in the reservoir which resulted in the inability to inflate the prosthesis.The physician noted that the tube connecting the pump to the reservoir was most likely disconnected.When he checked the patient, he felt the deflated reservoir outside the inguinal ring and stated that, due to the suspected fluid leak, the reservoir had likely migrated through the inguinal ring.

• 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
• 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: 16402473
• Report Number: 2124215-2023-07321
• Device Sequence Number: 16966557
• Product Code: FHW
• UDI-Device Identifier: 00878953005744
• UDI-Public: 00878953005744
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 02/27/2023

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: 10/27/2021
• Device Model Number: 72404303
• Device Catalogue Number: 72404303
• Device Lot Number: 0150532005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2023
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2016
• 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:720182-01/1000429185; RESERVOIR:720182-01/1000429185
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Male