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

Model Number	72404014
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
C2/d10: concomitant product udi for pump is (b)(4), c2/d10: concomitant product udi for reservoir is (b)(4).The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Fluid loss is acknowledged within the dfu and are not related to off label use or failure to follow instructions.The dfu provides guidance and instruction to achieve successful ams 700 implantation and to prevent fluid loss.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) implant device went to the hospital two weeks before the operation because the product was not working properly.Upon inspection, cracks were found in the cylinder and the pump connecting tubing.The physician removed and replaced the pump and cylinder through replacement surgery, the patient's condition was stable following the procedure, and there were no patient complications reported.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) implant device went to the hospital two weeks before the operation because the product was not working properly.Upon inspection, cracks were found in the cylinder and the pump connecting tubing.The physician removed and replaced the pump and cylinder through replacement surgery, the patient's condition was stable following the procedure, and there were no patient complications reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404310 serial number: n/a.Batch/lot number: 1100062434 model/catalog description: pump ms unique identifier (udi) #: (b)(4).Model number/catalog number: 720182-01 serial number: n/a.Batch/lot number: 190538008 model/catalog description: reservoir flat 100 ml unique identifier (udi) #: (b)(4).Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The cylinder and pump were visually and microscopically inspected, and leakage and functional tested.The visual inspection of the cylinder revealed that the cylinder had wear at the fold in the proximal end, middle, and distal end of the cylinder.The visual inspection of the pump revealed that the pump tubing was cut down to the pump block which is standard for the explant process.Tubing was not returned for analysis.The cylinder and pump components passed the leakage test.The functional test of the pump revealed that the pump failed activation 3.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.A risk review confirmed that the events of hole/perforated and mechanical issue were defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established for the crack allegation on the cylinder as no holes/leaks were identified and kink resistant tubing (krt) tubing was not returned for analysis.The pump not passing activation test 3 identified could have caused or contributed to the reported clinical observation of device not functioning.

• Brand Name: AMS 700 CXR
• 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 ; 5086521217
• MDR Report Key: 24338860
• Report Number: 2124215-2026-08377
• Device Sequence Number: 9799242
• Product Code: JCW
• UDI-Device Identifier: 00878953002712
• UDI-Public: (01)00878953002712(17)261117(10)1100032711
• 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: 2022
• Device Explanted Year: 2026
• 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): 04/02/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 72404014
• Device Catalogue Number: 72404014
• Device Lot Number: 1100032711
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2021
• 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: LOT 190538008 UPN 720182-01 RESERVOIR FLAT 100 ML.; LOT: 1100062434 UPN 72404310 PUMP MS.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male