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

Model Number	72404273
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) did not work properly.As a result of the inspection, it was confirmed that there was a crack in the right cylinder connecting tube.The right cylinder and the pump were explanted and replaced.No patient complications reported.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) did not work properly.As a result of the inspection, it was confirmed that there was a crack in the right cylinder connecting tube.The right cylinder and the pump were explanted and replaced.No patient complications reported.
Additional Manufacturer Narrative
D4.Concomitant product udi for pump is (b)(4) and for reservoir is (b)(4).Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The pump was microscopically inspected and tested for leaks.It was not functionally tested due to bodily fluid contamination identified within it.In addition, the pump stayed flat during leakage test and would not rebound normally.No leaks were identified in the component.The cylinder was microscopically inspected and tested for leaks.The microscope test found that the cylinder kink resistant tubing (krt) had a hole from wear, along with additional wear at the fold areas on the proximal, middle, and distal ends of the cylinder.Leaks were identified.Based on the information available and analysis results, the cylinder krt leak from wear confirmed the reported clinical observation of mechanical issue and the hole/perforation.

• Brand Name: AMS 700 CX
• 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: 21276994
• Report Number: 2124215-2025-04833
• Device Sequence Number: 3601400
• Product Code: JCW
• UDI-Device Identifier: 00878953003801
• UDI-Public: 00878953003801
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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: 03/03/2022
• Device Model Number: 72404273
• Device Catalogue Number: 72404273
• Device Lot Number: 0164366002
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PUMP MS, UPN 72404310, LOT 171496008; PUMP MS, UPN 72404310, LOT 171496008; RESERVOIR, UPN 720182-01, LOT 152208018; RESERVOIR, UPN 720182-01, LOT 152208018
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male