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

Model Number	72404438
Medical Device Problem Codes	Inflation Problem (1310); Use of Device Problem (1670); Defective Device (2588)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no device available for analysis.The reported patient symptoms are known risk associated with implants of these device as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.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 by a call that the inflatable penile prosthesis (ipp) device was partially inflated.It was informed the erection is half of what was naturally.It was also mentioned that the patient has not been able to inflate on his own and has attempted several times for more than 30 min in the bathtub without success and the pump was hard as a rock and he has induced pain to his scrotum.Some guides were provided to the patient about the correct device handling and the patient was able to inflate the cylinders and deflate as well.It was also explained differences between natural and prosthetic erection and realistic expectations of length loss and the patient was encouraged 2-3 per day to stretch tissue and potentially regain lost length.Another medical appointment was suggested to clarify all the concerns, but it was not accepted.

• Brand Name: AMS 700 CX 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: 21360635
• Report Number: 2124215-2025-06857
• Device Sequence Number: 8438225
• Product Code: JCW
• UDI-Device Identifier: 00191506021399
• UDI-Public: 00191506021399
• Combination Product (Y/N): Y
• 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
• Report Date (Section B): 02/11/2025

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 Expiration Date: 07/10/2026
• Device Model Number: 72404438
• Device Catalogue Number: 72404438
• Device Lot Number: 1100545447
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 02/11/2025
• Date Device Manufactured: 07/10/2024
• 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 Age: 68 YR
• Patient Sex: Male