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

Model Number	72404013
Medical Device Problem Codes	Degraded (1153); Mechanical Problem (1384); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product was manufactured prior to implementation of the udi regulation and as a result, the complete udi is not available.Applicable us product data has been included in this report.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.Mechanical issue and bulge are acknowledged within the dfu and are not related to off-label use or failure to follow instructions.Additionally, it is concluded that the cause of the allegation cannot be established without product return.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) presented with a nonfunctioning device.A revision surgery was performed, during which the physician confirmed that the right cylinder had a ballooning.The device was explanted and replaced.There were no patient complications.
Additional Manufacturer Narrative
Model number/catalog number: 72400152.Serial number: n/a.Batch/lot number: 671122002.Model/catalog description: reservoir.Model number/catalog number: 72401110.Serial number: n/a.Batch/lot number: 644410003.Model/catalog description: pump cxm.This product was manufactured prior to implementation of the udi regulation and as a result, the complete udi is not available.Applicable us product data has been included in this report.Upon receipt at the quality assurance laboratory, the returned components underwent evaluation, and the first cylinder exhibited a bulge during decontamination, which was punctured with a sharp instrument to release contaminated fluid.When inflated with a syringe, the first cylinder exhibited a bulge consistent with excess air between the inner and outer tubes and exhibited wear at a fold in the proximal end of the cylinder, with a hole identified in the outer tube consistent with kink resistant tubing (krt) wear.Additional wear was observed in the middle and distal sections, along with broken and detached fabric threads in the proximal end, and a hole and leak were identified in the middle of the cylinder, attributed to sharp instrument damage.The second cylinder exhibited wear at a fold in the proximal end of the cylinder, with additional wear observed in the middle and distal sections, and the second cylinder passed leakage testing.The standard inflate deflate pump exhibited krt worn to filament, and the outer layer of the pump bulb exhibited wear against the pump strain relief krt junction, with the krt exhibiting a hole and leak consistent with fatigue.The spherical reservoir exhibited wear at folds in the reservoir shell, with multiple folds observed, and the reservoir passed leakage testing.The device history record (dhr) review confirmed that the device met all material, assembly, and performance specifications.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.A risk review was completed and confirmed that the events of mechanical malfunction (leaks, incomplete inflation/ deflation, kinking), device has a fluid leak, and inconsistent cylinder diameter (aneurysm) 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 the information available and the analysis results, the first cylinder was confirmed to have a bulge during decontamination, and the bulge was punctured with a sharp instrument to release the contaminated fluid as it did not drain on its own.The cylinder bulge would lead to a mechanical issue as the cylinder could no longer inflate or deflate correctly.A conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with a nonfunctioning device.A revision surgery was performed, during which the physician confirmed that that the right cylinder had a ballooning.The device was explanted and replaced.There were no patient complications.

• 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
• MDR Report Key: 24431755
• Report Number: 2124215-2026-10170
• Device Sequence Number: 10297566
• 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: 2025
• 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): 05/19/2026

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: 72404013
• Device Catalogue Number: 72404013
• Device Lot Number: 1100575619
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PUMP LOT 644410003, UPN 72401110; PUMP LOT 644410003, UPN 72401110.; RESERVOIR LOT 671122002, UPN 72400152; RESERVOIR LOT 671122002, UPN 72400152.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male