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

Model Number	72404236
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number 72404155.Serial number n/a.Batch/lot number 1100014231.Model/catalog description reservoir 65 ml pc/iz.Unique identifier (udi) # (b)(4).
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) had been implanted with undersized cylinders, resulting in glans drooping and difficulty with penetration.A surgical procedure was performed during which the ipp was removed and replaced.The original 15 cm cylinders were exchanged for new 18 cm cylinders.No further patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number 72404155.Serial number n/a.Batch/lot number 1100014231.Model/catalog description reservoir 65 ml pc/iz.Unique identifier (udi) # (b)(4).There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.The reported issues with cylinder - length too short may have been due to a potential measurement error.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 length too short 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 of disfigurement is a known risk associated with this device type and indicated as such in the instructions for use.Based on the information available, a conclusion code of unintended use error caused or contributed to event was assigned to this investigation.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) had been implanted with undersized cylinders, resulting in glans drooping and difficulty with penetration.A surgical procedure was performed during which the ipp was removed and replaced.The original 15 cm cylinders were exchanged for new 18 cm cylinders.No further patient complications were reported.

• Brand Name: AMS 700 CX 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: 24677365
• Report Number: 2124215-2026-16172
• Device Sequence Number: 21367286
• Product Code: JCW
• UDI-Device Identifier: 00878953003498
• UDI-Public: (01)00878953003498(17)221017(10)1000474950
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: 10/17/2022
• Device Model Number: 72404236
• Device Catalogue Number: 72404236
• Device Lot Number: 1000474950
• 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: 02/27/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/24/2026
• Date Device Manufactured: 10/17/2020
• 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: 43 YR
• Patient Sex: Male