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

Model Number	72401452
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384); Failure to Deflate (4060)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 date of event: the exact event date is unknown.
Event or Problem Description
It was reported that the patient is experiencing difficulties inflating and deflating his ambicor penile prosthesis.The patient stated that the pump is hard as a rock and fluid does not seem to transfer in or out of the cylinders, the patient feels that the prosthesis is always at approximately 50% inflation.The patient has scrotal pain.The patient was evaluated by his physician, who confirmed the device operation difficulty, but suggested to wait two or three weeks, hoping it will resolve.Boston scientific patient services specialist suggested to attempt in the shower, which he already did.The patient wants to get a second opinion from another doctor.
Additional Manufacturer Narrative
B3 date of event: the exact event date is unknown.
Event or Problem Description
It was reported that the patient is experiencing difficulties inflating and deflating his ambicor penile prosthesis.The patient stated that the pump is hard as a rock and fluid does not seem to transfer in or out of the cylinders, the patient feels that the prosthesis is always at approximately 50% inflation.The patient has scrotal pain.The patient was evaluated by his physician, who confirmed the device operation difficulty, but suggested to wait two or three weeks, hoping it will resolve.Boston scientific patient services specialist suggested to attempt in the shower, which he already did.The patient wants to get a second opinion from another doctor.

• Brand Name: AMS AMBICOR 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20055570
• Report Number: 2124215-2024-52741
• Device Sequence Number: 8118199
• Product Code: FHW
• UDI-Device Identifier: 00878953000961
• UDI-Public: 00878953000961
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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: 11/30/2024
• Device Model Number: 72401452
• Device Catalogue Number: 72401452
• Device Lot Number: 1000364184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 09/23/2024
• Date Device Manufactured: 12/02/2019
• 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: Other
• Patient Age: 67 YR
• Patient Sex: Male