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

Model Number	72404251
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 720185-01, serial number: n/a , batch/lot number: 1100642159, model/catalog description: reservoir flat iz 100 ml, unique identifier (udi) # : (b)(4).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 device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The device instructions for use (ifu) was reviewed.The patient symptom of disfigurement was found to be listed in the ifu.A risk review was completed and confirmed that the event of disfigurement and malposition of device was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.The reported patient symptom is a known risk associated with this device type.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with a device that was not positioned correctly.A revision surgery was performed, during which a supersonic transport deformity at the glans was confirmed, and it was stated that the mispositioning was present immediately following the initial procedure and did not appear to be related to migration.Upon remeasurement, corporal measurements were reported to be unchanged, and it was believed that the mispositioning was most likely associated with dilation issues during the initial procedure rather than a device sizing or migration issue.The device was explanted and replaced.No further patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 720185-01 serial number: n/a batch/lot number: 1100642159 model/catalog description: reservoir flat iz 100 ml unique identifier (udi) # : (b)(4).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.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 disfigurement and malposition of device 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, a conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with a device that was not positioned correctly.A revision surgery was performed, during which a supersonic transport deformity at the glans was confirmed, and it was stated that the mispositioning was present immediately following the initial procedure and did not appear to be related to migration.Upon remeasurement, corporal measurements were reported to be unchanged, and it was believed that the mispositioning was most likely associated with dilation issues during the initial procedure rather than a device sizing or migration issue.The device was explanted and replaced.No further patient complications were 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: 24690047
• Report Number: 2124215-2026-16382
• Device Sequence Number: 9726944
• Product Code: JCW
• UDI-Device Identifier: 00878953003597
• UDI-Public: (01)00878953003597(17)240203(10)1100080509
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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,Followup
• Report Date (Section B): 04/23/2026

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: 02/03/2024
• Device Model Number: 72404251
• Device Catalogue Number: 72404251
• Device Lot Number: 1100080509
• 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: 02/24/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/23/2026
• Date Device Manufactured: 02/03/2022
• 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: 69 YR
• Patient Sex: Male