MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700¿ CX TENACIO¿ Pump; prosthesis, penis, inflatable

Model Number	72404433
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the pump of this inflatable penile prosthesis (ipp) presented a tubing break.A surgical procedure was performed during which the existing pump was explanted and replaced with a new one.There were no patient complications reported.
Additional Manufacturer Narrative
Model number/catalog number: 720185-01, batch/lot number: 1100851970, model/catalog description: reservoir flat iz 100 ml, unique identifier (udi) #: (b)(4).

• 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: 50515482
• Report Number: 2124215-2026-46210
• Device Sequence Number: 21134676
• Product Code: JCW
• UDI-Device Identifier: 00191506021344
• UDI-Public: (01)00191506021344(17)270828(10)1100786043
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/29/2026

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 Model Number: 72404433
• Device Catalogue Number: 72404433
• Device Lot Number: 1100786043
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/31/2026
• Date Device Manufactured: 08/28/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male