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

Model Number	72404292
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) went to the hospital because the product did not work properly.Two weeks later a surgery was performed, as a result of the inspection, it was confirmed that the left cylinder had a hole.The left cylinder and pump were explanted and replaced.No patient complications reported.
Additional Manufacturer Narrative
D4.Concomitant product udi for pump is (b)(4).
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) went to the hospital because the product did not work properly.Two weeks later a surgery was performed, as a result of the inspection, it was confirmed that the left cylinder had a hole.The left cylinder and pump were explanted and replaced.No patient complications reported.
Additional Manufacturer Narrative
D4.Concomitant product udi for pump is (b)(4).Correction to field g2: report source.Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The pump was microscopically inspected, functionally and leak tested.The microscope test revealed that the pump tubing was cut down to the pump block.The pump passed functional testing.No leaks were identified.The cylinder was microscopically inspected, and leak tested.The microscope test identified that the cylinder had two holes at corner of folds in the proximal end of the cylinder and had wear at fold in the proximal end, middle, and distal end of the cylinder.Leaks were identified.Based on the information available and analysis results, the reported mechanical issue and cylinder - hole/perforated were confirmed.

• 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: 21993499
• Report Number: 2124215-2025-29489
• Device Sequence Number: 20975525
• Product Code: JCW
• UDI-Device Identifier: 00878953003948
• UDI-Public: (01)00878953003948(17)210201(10)120118004
• 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: 2024
• 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): 07/01/2025

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: 02/01/2021
• Device Model Number: 72404292
• Device Catalogue Number: 72404292
• Device Lot Number: 120118004
• 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: 04/18/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 07/01/2025
• Date Device Manufactured: 02/18/2016
• 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 1100539868.; PUMP: UPN 72404310/ LOT 1100539868.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Unknown