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

Model Number	72404012
Medical Device Problem Codes	Nonstandard Device (1420); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to the hospital two weeks prior to surgery and during examination it was observed that there was a crack in the right cylinder connection tube of their artificial urinary sphincter (aus) implant device.The physician removed and replaced the right cylinder through replacement surgery, and the patient's condition was stable and improved following the surgery.There were no further signs or symptoms reported.
Additional Manufacturer Narrative
H6: 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.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 presented to the hospital two weeks prior to surgery and during examination it was observed that there was a crack in the right cylinder connection tube.The physician removed and replaced the right cylinder through replacement surgery, and the patient's condition was stable and improved following the surgery.There were no further signs or symptoms reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The cylinders and pump were visually inspected and leak tested.Cylinder 1 had two holes and two leaks at the corners of a fold in the proximal end of the cylinder, and cylinder 1 had wear at fold in the proximal end, middle, and distal end of the cylinder.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications prior to distribution, and there were no manufacturing deviations which could have contributed to the reported event.A risk review confirmed that this event was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.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 and analysis results, the cylinder leaks at the corner of a fold identified with the cylinder could have caused or contributed to the reported clinical observations of hole/perforated.

• 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: 23822353
• Report Number: 2124215-2025-91262
• Device Sequence Number: 18463027
• Product Code: JCW
• UDI-Device Identifier: 00878953002699
• UDI-Public: (01)00878953002699(17)230121(10)1000034418
• 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: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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 Expiration Date: 01/21/2023
• Device Model Number: 72404012
• Device Catalogue Number: 72404012
• Device Lot Number: 1000034418
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2018
• 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: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male