MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 CXR; prosthesis, penis, inflatable

Model Number	72404014
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Tissue Injury (4559)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) cylinder protruded through the distal aspect of the penis.A surgical procedure was performed during which the ipp was explanted.Reimplantation of a new device was planned for a later date.No additional patient complications were reported.
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) cylinder protruded through the distal aspect of the penis.A surgical procedure was performed during which the ipp was explanted.Reimplantation of a new device was planned for a later date.It was reported that the extrusion was attributed to device displacement resulting from long-term wear.No additional patient complications were reported.
Additional Manufacturer Narrative
Concomitant products implanted at the time of the event: model number/catalog number: 72018201 serial number: n/a batch/lot number: 1000528625 model/catalog description: reservoir flat 100 ml unique identifier (udi) #: (b)(4) model number/catalog number: 72404310 serial number: n/a batch/lot number: 1100069841 model/catalog description: pump ms unique identifier (udi) #: (b)(4).
Additional Manufacturer Narrative
Concomitant products implanted at the time of the event: model number/catalog number: 72018201 serial number: n/a batch/lot number: 1000528625 model/catalog description: reservoir flat 100 ml unique identifier (udi) #: (b)(4).Model number/catalog number: 72404310 serial number: n/a batch/lot number: 1100069841 model/catalog description: pump ms unique identifier (udi) #: (b)(4).

• Brand Name: AMS 700 CXR
• 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: 50515458
• Report Number: 2124215-2026-45749
• Device Sequence Number: 13440841
• Product Code: JCW
• UDI-Device Identifier: 00878953002712
• UDI-Public: (01)00878953002712(17)261221(10)1100061702
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 72404014
• Device Catalogue Number: 72404014
• Device Lot Number: 1100061702
• 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: 08/06/2026
• Supplement Date Received by Manufacturer: 08/30/2026
• Initial Report FDA Received Date: 08/31/2026
• Supplement Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 12/22/2021
• 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: 37 YR
• Patient Sex: Male