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

Model Number	72404301
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not working properly; therefore, a surgical procedure was performed to remove the device, and a future revision surgery is planned.There were no patient complications reported.
Additional Manufacturer Narrative
Additional information updated: b3: date of event.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not working properly; therefore, a surgical procedure was performed to remove the device, and a future revision surgery is planned.There were no patient complications reported.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not working properly; therefore, a surgical procedure was performed to remove the device, and a future revision surgery is planned.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.Both cylinders were microscopically inspected and tested for leaks.Wear at fold was noted in the proximal end of each cylinder, but no leaks were identified.The pump was microscopically inspected, leak and functionally tested.No damage or abnormalities were noted upon microscopic evaluation, and no leaks were identified; however, the component did not pass activation testing during functional examination.The reservoir was microscopically inspected and tested for leaks, and a hole and a leak were noted, consistent with sharp instrument damage.Based on the information available and analysis results, the pump not passing functional evaluation could have caused or contributed to the reported clinical observation of device not working properly.Concomitant product udi for reservoir is (b)(4).

• 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: 20397411
• Report Number: 2124215-2024-62681
• Device Sequence Number: 3378563
• Product Code: JCW
• UDI-Device Identifier: 00878953005720
• UDI-Public: (01)00878953005720(17)280423(10)1100291571
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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,Followup
• Report Date (Section B): 04/04/2025

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 Model Number: 72404301
• Device Catalogue Number: 72404301
• Device Lot Number: 1100291571
• 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: 09/18/2024
• Supplement Date Received by Manufacturer: 11/11/2024; 03/18/2025
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 11/26/2024; 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2023
• 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: RESERVOIR: UPN: 72401461 / LOT: 1100383404.; RESERVOIR: UPN: 72401461 / LOT: 1100383404.; RESERVOIR: UPN: 72401461 / LOT: 1100383404.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male