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

Model Number	72404174
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Erosion (1750)
Date of Event	02/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The exact event date was not available, therefore the date 02/01/2025 was used as an estimate, since it was reported that the event occurred during recovery period.Udi field (d4) concomitant product udi for reservoir is udi (b)(4).
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis presented with a breakdown of the corporotomy closure, causing the right cylinder to extrude outside the corporal body.A revision surgery was performed, during which the right cylinder was repositioned into the corpus cavernosum, and a tighter, more secure closure was applied.No components were explanted or replaced, and no further patient complications were reported.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis ipp presented with a breakdown of the corporotomy closure, causing the right cylinder to extrude outside the corporal body.A revision surgery was performed, during which the right cylinder was repositioned into the corpus cavernosum, and a tighter, more secure closure was applied.No components were explanted or replaced, and no further patient complications were reported.
Additional Manufacturer Narrative
The exact event date was not available, therefore the date 02/01/2025 was used as an estimate, since it was reported that the event occurred during recovery period.Udi field (d4) concomitant product udi for reservoir is udi (b)(4).There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms of dehiscence and extrusion are known risks associated with implant of these device as indicated in the instructions for use (ifu).As a result, the conclusion code cause not established was assigned.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) presented with a breakdown of the corporotomy closure, causing the right cylinder to extrude outside the corporal body.A revision surgery was performed, during which the right cylinder was repositioned into the corpus cavernosum, and a tighter, more secure closure was applied.No components were explanted or replaced, and no further patient complications were reported.
Additional Manufacturer Narrative
The exact event date was not available, therefore the date 02/01/2025 was used as an estimate, since it was reported that the event occurred during recovery period.Udi field (d4) concomitant product udi for reservoir is udi (b)(4).There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms of dehiscence, extrusion and migration are known risks associated with implant of these device as indicated in the instructions for use (ifu).As a result, the conclusion code cause not established was assigned.
Additional Manufacturer Narrative
The exact event date was not available, therefore the date 02/01/2025 was used as an estimate, since it was reported that the event occurred during recovery period.Udi field (d4) concomitant product udi for reservoir is udi (b)(4).Correction to field h11: additional mfr narrative.The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Dehiscence, extrusion, and migration were 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 allegations of dehiscence, extrusion, and migration are known risk associated with this device type and indicated as such in the instructions for use.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) presented with a breakdown of the corporotomy closure, causing the right cylinder to extrude outside the corporal body.A revision surgery was performed, during which the right cylinder was repositioned into the corpus cavernosum, and a tighter, more secure closure was applied.No components were explanted or replaced, and no further patient complications were reported.

• Brand Name: AMS 700 CX
• 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: 21988775
• Report Number: 2124215-2025-29617
• Device Sequence Number: 8312149
• Product Code: JCW
• UDI-Device Identifier: 00878953003283
• UDI-Public: (01)00878953003283(17)260716(10)1100547918
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup,Followup
• Report Date (Section B): 12/01/2025

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: 07/16/2026
• Device Model Number: 72404174
• Device Catalogue Number: 72404174
• Device Lot Number: 1100547918
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 06/02/2025; 08/15/2025; 11/04/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 06/30/2025; 09/12/2025; 12/01/2025
• Date Device Manufactured: 07/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR UPN 72404155 LOT 1100366175.; RESERVOIR UPN 72404155 LOT 1100366175.; RESERVOIR UPN 72404155 LOT 1100366175.; RESERVOIR UPN 72404155 LOT 1100366175.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male