MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 TENACIO PUMP; PROSTHESIS, PENIS, INFLATABLE

Model Number	72404420
Medical Device Problem Codes	Inflation Problem (1310); Migration (4003); Failure to Deflate (4060)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Swelling/ Edema (4577)
Date of Event	12/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced discomfort, swelling and pain in the scrotum due to pump placement.It was noted that the reservoir had herniated.The pump also rotated and it was difficult to find.It was difficult to inflate and deflate the device.There is a revision procedure booked.There were no further patient complications reported.

• Brand Name: AMS 700 TENACIO PUMP
• Common Device Name: PROSTHESIS, PENIS, INFLATABLE
• 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: 21125971
• Report Number: 2124215-2024-83614
• Device Sequence Number: 15159687
• Product Code: JCW
• UDI-Device Identifier: 00191506021290
• UDI-Public: 00191506021290
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2025

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 Model Number: 72404420
• Device Catalogue Number: 72404420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 01/10/2025
• 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 Sex: Male
• Patient Race: Black Or African American