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

Model Number	72404256
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 72018501.Serial number: n/a.Batch/lot number: 1000314784.Model/catalog description: reservoir flat iz 100 ml.Unique identifier (udi) #: (b)(4).Upon receipt at the quality assurance laboratory, the returned components underwent a comprehensive evaluation.The ms pump passed visual inspection with no damage or abnormalities observed and passed the leakage test; however, the ms pump not passed activation tests 2 and 3.The first cylinder exhibited wear at a fold in the proximal end of the cylinder, with a hole identified in the outer tube consistent with kink resistant tubing (krt) wear, resulting in a leak at the proximal end.The second cylinder also exhibited wear at a fold in the proximal end of the cylinder, with a hole identified in the outer tube consistent with krt wear; however, the second cylinder passed the leakage test.The flat reservoir passed visual inspection with no damage or abnormalities observed and passed the leakage test.The 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 issue and fluid leak 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 the analysis results, the ms pump not passing activation tests 2 and 3 and the first cylinder having a leak from kink resistant tubing (krt) wear at the proximal end could have caused or contributed to the device being removed.A conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
This product was returned to the manufacturer without any report of performance issues or adverse patient effects.The returned device was analyzed and a non conformance was identified.See additional manufacturer narrative for full investigation details.

• 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: 24572229
• Report Number: 2124215-2026-13742
• Device Sequence Number: 9434540
• Product Code: JCW
• UDI-Device Identifier: 00878953003641
• UDI-Public: (01)00878953003641(17)210620(10)1000293744
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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 Expiration Date: 06/20/2021
• Device Model Number: 72404256
• Device Catalogue Number: 72404256
• Device Lot Number: 1000293744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0427-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown