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

Model Number	72404012
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	02/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 72404310, serial number: n/a, batch/lot number: 1000211777, model/catalog description: pump ms, unique identifier (udi) #: (b)(4).Model number/catalog number: 72404161, serial number: n/a, batch/lot number: 1000169149, model/catalog description: reservoir 65ml pc, unique identifier (udi) #: (b)(4).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.A risk review was completed and confirmed that the events of device damage and mechanical issues were defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) presented to the hospital with a non-functional device.Two weeks later, a surgical procedure was performed and upon inspection, there was a hole found in the right cylinder.As a result, the physician removed and replaced the right cylinder.The patient was stable following the procedure, and there were no patient complications reported.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) presented to the hospital with a non-functional device.Two weeks later, a surgical procedure was performed and upon inspection, there was a hole found in the right cylinder.As a result, the physician removed and replaced the right cylinder.The patient 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: 1000211777.Model/catalog description: pump ms.Unique identifier (udi) #: (b)(4).Model number/catalog number: 72404161.Serial number: n/a.Batch/lot number: 1000169149.Model/catalog description: reservoir 65ml pc.Unique identifier (udi) #: (b)(4).B1 corrected.Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The microscopic visual inspection of the cylinder revealed that the cylinder had wear at a fold in the proximal end and distal end of the cylinder, and a hole at a corner of a fold in the proximal end of the cylinder.The leakage test of the cylinder revealed that the cylinder had a leak at a corner of a fold in the proximal end of the cylinder.Hole and mechanical issues are acknowledged within the instructions for use (ifu) and is not related to off label use or failure to follow instructions.A risk review confirmed that the events of hole and mechanical issues are 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, a conclusion code of cause traced to component failure was assigned to this investigation due to the cylinder leak at the corner of a fold from the functional test performed and the analysis of the available information.The fluid loss from the cylinder would result in a mechanical issue because if any part of the system leaks, the devices can no longer maintain pressure and will not function correctly when the pump is activated.

• 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: 24678143
• Report Number: 2124215-2026-15962
• Device Sequence Number: 13315908
• Product Code: JCW
• 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: 2019
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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: 01/15/2024
• Device Model Number: 72404012
• Device Catalogue Number: 72404012
• Device Lot Number: 1000211852
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2019
• 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: 66 YR
• Patient Sex: Male