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

Model Number	72404251
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	03/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.The reported patient symptom(s) are known risk associated with this device type and indicated as such in the instructions for use.Model number/catalog number: 72404155.Serial number: n/a.Batch/lot number: 528744002.Model/catalog description: reservoir 65 ml pc/iz.D4 unique identifier (udi): (b)(4).
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) presented with fractured tubing and cylinder fell inside the scrotum, the device presented a mechanical problem and a fluid loss.The ipp was explanted and replaced.There is no additional information reported.

• 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: 24791731
• Report Number: 2124215-2026-18557
• Device Sequence Number: 18644988
• Product Code: JCW
• UDI-Device Identifier: 00878953003597
• UDI-Public: (01)00878953003597(17)091019(10)521888006
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/06/2026

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: 10/19/2009
• Device Model Number: 72404251
• Device Catalogue Number: 72404251
• Device Lot Number: 521888006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2026
• Initial Report FDA Received Date: 04/06/2026
• Date Device Manufactured: 10/30/2007
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male