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

Model Number	72404252-10
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	08/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the initial placement of an inflatable penile prosthesis (ipp), a distal corporal perforation occurred, which resulted in the placement of only one cylinder.Following the procedure, the patient did not achieve satisfactory outcomes with the implant.Consequently, a subsequent surgical intervention was performed.During this procedure, the previously placed single cylinder was removed and replaced with two new cylinders and a pump.The original reservoir was retained, drained and subsequently refilled.No additional patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 720185-01 serial number: n/a batch/lot number: 1100536498 model/catalog description: reservoir flat iz 100 ml unique identifier (udi) #: (b)(4).The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.The patient symptom is a known risk associated with this device type/procedure, and it is noted as such as in the instructions for use.Based on the information available, the conclusion codes of caused not established and known inherent risk of device were assigned to this investigation.

• 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: 25116543
• Report Number: 2124215-2026-24884
• Device Sequence Number: 9321560
• Product Code: JCW
• UDI-Device Identifier: 00878953009810
• UDI-Public: (01)00878953009810(17)260612(10)1100530329
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/07/2026

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: 06/12/2026
• Device Model Number: 72404252-10
• Device Catalogue Number: 72404252-10
• Device Lot Number: 1100530329
• 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: 04/17/2026
• Initial Report FDA Received Date: 05/07/2026
• Date Device Manufactured: 06/12/2024
• 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: Required Intervention; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Unknown