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

Model Number	72404293
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	12/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Field g4: premarket / 510(k) # exceeds the minimum character limit allowed; the complete number is n970012/p000053.Concomitant product udi for pump is (b)(4).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 the patient went to the clinic because this inflatable penile prosthesis (ipp) was not working properly.Two weeks later, a surgical procedure was performed, during which a crack in the cylinder connecting tube was identified.The cause of the crack in the connecting tube was not detailed by the hospital.The cylinders and pump were removed and replaced.No patient complications were reported.
Event or Problem Description
It was reported that the patient went to the clinic because this inflatable penile prosthesis (ipp) was not working properly.Two weeks later, a surgical procedure was performed, during which a crack in the cylinder connecting tube was identified.The cause of the crack in the connecting tube was not detailed by the hospital.The cylinders and pump were removed and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Field g4: premarket / 510(k) # exceeds the minimum character limit allowed; the complete number is n970012/p000053.Model number/catalog number 72404310 serial number n/a batch/lot number 1000332083 model/catalog description pump ms unique identifier (udi) # (b)(4).Upon receipt at our quality assurance laboratory, the cylinders and pump of this inflatable penile prosthesis (ipp) underwent a thorough analysis.The cylinders were microscopically inspected and tested for leaks.The first cylinder kink resistant tubing (krt) had a hole from sharp instrument damage.The first cylinder had wear at fold in the proximal end and distal end of the cylinder.The first cylinder kink resistant tubing (krt) had a leak from sharp instrument damage.The second cylinder had a hole in the proximal end of the cylinder from sharp instrument.The second cylinder had wear at fold in the proximal end and distal end of the cylinder.The second cylinder had a leak from sharp instrument in the proximal end of the cylinder.The ms pump was microscopically inspected, leak and functionally tested.The pump passed the visual inspection.No damage or abnormalities were found.No leaks were found in the pump.The pump did not pass the activation tests 2 and 3.Based on the investigation available and analysis results, the reported allegation of mechanical issue and hole/perforated are unable to be confirmed as the sharp instrument damage found in the cylinders is considered a secondary failure.However, the pump not passing the functional test could affect the product performance.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) and device has a fluid leak 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, a conclusion code of cause traced to component failure was assigned to this investigation.

• Brand Name: AMS 700 LGX
• 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: 24111850
• Report Number: 2124215-2026-03469
• Device Sequence Number: 5430326
• Product Code: JCW
• UDI-Device Identifier: 00878953003955
• UDI-Public: (01)00878953003955(17)190623(10)889210004
• 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: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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: 06/23/2019
• Device Model Number: 72404293
• Device Catalogue Number: 72404293
• Device Lot Number: 889210004
• 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: 12/28/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2014
• 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: UPN: 72404310 / LOT: 1000332083.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male