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	08/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4.Concomitant product udi for pump is (b)(4) and for reservoir is (b)(4).G4: pma/510(k) # field on 3500a form is n970012, p000053 - reported here as pma # exceeded character limit for designated field.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) visited the hospital because the product did not function properly.Two weeks later upon inspection, it was confirmed that the left cylinder had a hole, so the left cylinder and the pump were explanted and replaced.No patient complications reported.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) visited the hospital because the product did not function properly.Two weeks later upon inspection, it was confirmed that the left cylinder had a hole, so the left cylinder and the pump were explanted and replaced.No patient complications reported.
Additional Manufacturer Narrative
D4.Concomitant product udi for pump is (b)(4) and for reservoir is (b)(4).G4: pma/510(k) # field on 3500a form is n970012, p000053 - reported here as pma # exceeded character limit for designated field.Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) cylinder and pump underwent a thorough analysis.The pump was microscopically inspected, functionally and leak tested.Under microscope observation, contamination (bodily fluid) was found within the ms pump.As a result, the functional test was not performed.The pump tubing was cut down to the pump block; the tubing was returned attached to the cylinders.No leaks were identified.The cylinder was microscopically inspected, and leak tested.The microscope test found that the cylinder had at corner of a fold in the proximal end of the cylinder and had wear at fold in the proximal end and distal end of the cylinder.The cylinder did not pass the leak test.Based on the information available and analysis results, the hole/leak at the corner of a fold in the first cylinder confirmed the reported clinical observation of device- mechanical issue and cylinder - hole/perforated.

• 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: 23127809
• Report Number: 2124215-2025-66712
• Device Sequence Number: 15267743
• Product Code: JCW
• UDI-Device Identifier: 00878953003955
• UDI-Public: (01)00878953003955(17)210520(10)135694004
• 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: 2017
• 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): 12/18/2025

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: 05/20/2021
• Device Model Number: 72404293
• Device Catalogue Number: 72404293
• Device Lot Number: 0135694004
• 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: 09/01/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2016
• 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: UPN: 7240182-01 LOT: 128306006 - RESERVOIR.; UPN: 7240182-01 LOT: 128306006 - RESERVOIR.; UPN: 72404310 LOT: 149291005 - PUMP.; UPN: 72404310 LOT: 149291005 - PUMP.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male