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

Model Number	72404302
Medical Device Problem Codes	Collapse (1099); Inflation Problem (1310); Mechanical Problem (1384); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 unique identifier (udi) for reservoir: (b)(4).
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) presented an inflation problem, it was reported that the pump stays flat.The ipp was explanted and replaced.There were no patient complications reported.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) presented an inflation problem, it was reported that the pump stays flat.The ipp was explanted and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Concomitant components: model number/catalog number: (b)(6).Serial number: n/a.Batch/lot number: 1000566546.Model/catalog description: reservoir flat 100 ml.D4 unique identifier (udi): (b)(4).Upon receipt at our quality assurance laboratory, this device underwent a thorough analysis.The cylinders, pump and reservoir were microscopically examined, and leak tested; the pump was also functionally tested.Testing of the first cylinder revealed that there was a hole in the middle of the cylinder from sharp instrument damage, and wear at a fold in the middle of the cylinder; leakage testing confirmed a leak at the same location.Regarding the second cylinder, microscopic examination revealed wear at a fold in the middle of the cylinder; however, this component passed leakage testing.The momentary squeeze (ms) pump passed visual inspection and leakage testing, but it did not pass activation tests.Finally, regarding the flat reservoir, microscopic examination revealed a hole at the reservoir adapter strain relief from sharp instrument damage.Leakage testing confirmed a leak at the reservoir adapter strain relief, while the reservoir shell itself passed leakage testing.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 event of mechanical malfunction (leaks, incomplete inflation/ deflation, kinking) was 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 and analysis results, the ms pump not passing the activation tests could have caused or contributed to the reported clinical observation of mechanical problem.

• 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: 22290129
• Report Number: 2124215-2025-39006
• Device Sequence Number: 18236043
• Product Code: JCW
• UDI-Device Identifier: 00878953005737
• UDI-Public: (01)00878953005737(17)280419(10)1100291020
• 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: 2023
• 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
• Report Date (Section B): 03/25/2026

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 Model Number: 72404302
• Device Catalogue Number: 72404302
• Device Lot Number: 1100291020
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2023
• 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 (B)(6) / LOT 1000566546; RESERVOIR: UPN (B)(6) / LOT 1000566546
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 27 YR
• Patient Sex: Male