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

Model Number	72404253
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the inflatable penile prosthesis (ipp) left cylinder presented a rupture.A surgical procedure was performed to replace the system.There were no patient complications.
Event or Problem Description
It was reported that the inflatable penile prosthesis (ipp) left cylinder rupture presented a rupture.A surgical procedure was performed to replace the system.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt of this inflatable penile prosthesis (ipp) at our quality assurance laboratory, this device was thoroughly analyzed.The microscopic examination confirmed the first cylinder had a hole in the outer tube from krt (kink resistant tubing) wear in the proximal end of the cylinder, it had a hole at corner of a fold in the middle of the cylinder and a fold in the proximal end and middle of the cylinder.The second cylinder presented a hole in the outer tube from krt wear in the proximal end of the cylinder.It also had wear at fold in the proximal end, middle, and distal end of the cylinder.The microscopic analysis for the pump concluded the pump krt were worn to the filament.The device was also tested.The leakage test for first cylinder found that it had a leak at corner of a fold in the middle of the cylinder, it had a leak from krt input tube wear at the proximal end; the leakage test for second cylinder found that it had a leak at corner of a fold in the middle of the cylinder; however, the second cylinder passed leakage test.The pump was also tested, indicating it passed leak test but did not pass the functional test.It is likely that the cylinder fracture was most likely determined to be a hole/leak at the corner of a fold and a leak from krt wear from the functional test performed and the analysis.The reported complaint was confirmed.Based on review of all information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the inflatable penile prosthesis (ipp) left cylinder rupture presented a rupture.A surgical procedure was performed to replace the system.There were no patient complications.

• Brand Name: AMS 700 LGX MS PUMP
• 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: 21699892
• Report Number: 2124215-2025-18077
• Device Sequence Number: 7910050
• Product Code: JCW
• UDI-Device Identifier: 00878953003610
• UDI-Public: (01)00878953003610(17)210604(10)1000285523
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2025

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: 06/04/2021
• Device Model Number: 72404253
• Device Catalogue Number: 72404253
• Device Lot Number: 1000285523
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 03/26/2025; 05/12/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/09/2025; 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2019
• 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 Sex: Unknown