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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure involving an inflatable penile prosthesis (ipp) was cancelled due to unspecified reasons.There were no patient complications.No additional information was provided.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.
Event or Problem Description
It was reported that the procedure involving an inflatable penile prosthesis (ipp) was cancelled due to unspecified reasons.There were no patient complications.No additional information was provided.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the accessory kit of this inflatable penile prosthesis (ipp) underwent a thorough analysis.The accessory kit was visually inspected.All pieces were returned and passed the visual inspection.The proximal tool was visually inspected.Visual examination revealed that the proximal tool was broken in two places: at the 3cm and 4cm mark.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 event of intraoperative device/tool/accessory change was 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 analysis results, the reported allegation of no known device problem is unable to be confirmed.Based on the information available, a conclusion code of cause not established was assigned to this investigation.

• 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: 24605971
• Report Number: 2124215-2026-14338
• Device Sequence Number: 18740339
• Product Code: JCW
• UDI-Device Identifier: 00878953001135
• UDI-Public: (01)00878953001135(17)310121(10)1100880845
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 72401850
• Device Catalogue Number: 72401850
• Device Lot Number: 1100880845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2026
• 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
• Patient Sex: Unknown