MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 Accessory Kit; prosthesis, penis, inflatable

Model Number	72401850
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Tissue Injury (4559)
Date of Event	10/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.The reported patient symptom is a known risk associated with this device type and indicated as such in the instructions for use.
Event or Problem Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) procedure for erectile dysfunction, but the surgery was not completed due to a urethral injury that occurred during catheter placement.Cystoscopy confirmed urethral erosion.The accessory kit was opened but not used, and the procedure was aborted.There were no further patient complications reported.
Event or Problem Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) procedure for erectile dysfunction, but the surgery was not completed due to a urethral injury that occurred during catheter placement.Cystoscopy confirmed urethral erosion.The accessory kit was opened but not used, and the procedure was aborted.There were no further patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis underwent a thorough analysis.The accessory kit was visually inspected.Upon its examination, no damage or abnormalities were identified.The device history record (dhr) 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 "erosion" and "tissue damage" 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 reported patient symptoms of erosion and tissue damage are known risks associated with this device type and indicated as such in the instructions for use.Based on the information available and analysis results, a conclusion code of adverse even related to procedure was chosen for the investigation.This record was identified during a retrospective review of complaint events; an electronic medical device report (emdr) was not previously submitted per applicable reporting criteria.Boston scientific has opened a nonconforming events and prevention investigation (ncep-00181844) to determine the potential cause for why an emdr was not previously submitted to the food and drug administration (fda) in accordance with boston scientific's established medical device reporting process and fda adverse event reporting requirements.Information gained through these investigation efforts will be utilized to take action(s), as necessary.

• Brand Name: AMS 700 Accessory Kit
• 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: 23882955
• Report Number: 2124215-2025-92807
• Device Sequence Number: 9622611
• Product Code: JCW
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 72401850
• Device Catalogue Number: 72401850
• Device Lot Number: 1100796370
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/04/2025
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2025
• 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: Other
• Patient Sex: Unknown