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

Model Number	72404282
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Deformity/ Disfigurement (2360)
Date of Event	04/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not working.The patient experienced induration at the root of the patient penis was palpated by the physician.The cylinders were explanted and replaced.It was noticed that the device was damaged.No further patient complications reported.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not working.The patient presented with induration at the base of the penis, which was confirmed upon palpation by the physician.During surgical intervention, the cylinders were explanted and replaced.Device damage was noted at the time of removal.No further patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The pump was microscopically inspected, functionally and leak tested.No anomalies were found with the pump.The cylinders were microscopically inspected, and leak tested.The microscope test revealed that the first cylinder had a hole in the outer tube from sharp instrument damage in the proximal end of the cylinder.Both cylinders had wear at fold in the proximal end and distal end of the cylinder.No leaks were identified.Based on the information available and analysis results, the reported clinical observation of mechanical issue was not confirmed.The reported inflammation and disfigurement were confirmed as known inherent risks associated with implant of these device as indicated in the instructions for use (ifu).Correction to field b5: describe event or problem.

• Brand Name: AMS 700 CX MS 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: 22095541
• Report Number: 2124215-2025-34015
• Device Sequence Number: 15459440
• Product Code: JCW
• UDI-Device Identifier: 00878953003856
• UDI-Public: (01)00878953003856(17)290124(10)1100433419
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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: 72404282
• Device Catalogue Number: 72404282
• Device Lot Number: 1100433419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/15/2025
• Date Device Manufactured: 01/26/2024
• 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: 36 YR
• Patient Sex: Male
• Patient Weight: 75 KG