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

Model Number	72404267
Medical Device Problem Codes	Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Scar Tissue (2060)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date is unknown, so estimated date was entered.D10: concomitant product udi for reservoir is (b)(4).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Erosion is acknowledged within the ifu and are not related to off label use or failure to follow instructions.The ifu provides guidance and instruction to achieve successful ams 700 implantation and to prevent erosion related symptoms.Scarring is acknowledged within the ifu and are not related to off label use or failure to follow instructions.The ifu provides guidance and instruction to achieve successful ams 700 implantation and to prevent tissue damage related symptoms.The reported patient symptom(s) 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 an inflatable penile prosthesis (ipp) implant device had an explant surgery and during explant surgery, there was a pinpoint exposure of the pump in the right scrotum, and an exposed cylinder at the urethral meatus indicative of erosion.A transverse incision was made at the penoscrotal junction, and this was the site of the patient's prior incision and scar tissue was seen.A catheter could not be placed during this point of the procedure due to the eroded cylinder at the meatus, so the physician dissected down towards the corpora.At the time when the physician removed the cylinder components, they passed a flexible cystoscope into the meatus and into the left corpora which they noted distal scarring/erosion.All ipp implant device components were removed during the explant surgery, and there were no further patient complications reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404155 serial number: n/a batch/lot number: 0178948018 model/catalog description: reservoir 65 ml pc/iz unique identifier (udi) #: (b)(4).Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) implant device underwent a thorough analysis.The cylinder and pump components were visually inspected, and leak tested.The visual inspection of the cylinders revealed cylinder 1 had a hole in the proximal end of the cylinder from a sharp instrument, and cylinder 2 outer tube had holes in the proximal end of the cylinder from a sharp instrument.The visual inspection of the pump revealed a hole from a sharp instrument.The leak test revealed that cylinder 1 and the pump had a fluid leak.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications prior to distribution, and there were no manufacturing deviations which could have contributed to the reported event.A risk review confirmed that this event was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Erosion is acknowledged within the ifu and are not related to off label use or failure to follow instructions.The ifu provides guidance and instruction to achieve successful ams 700 implantation and to prevent erosion related symptoms.Scarring is acknowledged within the ifu and are not related to off label use or failure to follow instructions.The ifu provides guidance and instruction to achieve successful ams 700 implantation and to prevent tissue damage related symptoms.Sharp instrument damage was identified but it did not impact the event as the finding was secondary to what was initially reported; however, it cannot be confirmed when and/or how this damage occurred.The reported patient symptoms 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 an inflatable penile prosthesis (ipp) implant device had an explant surgery and during explant surgery, there was a pinpoint exposure of the pump in the right scrotum, and an exposed cylinder at the urethral meatus indicative of erosion.A transverse incision was made at the penoscrotal junction, and this was the site of the patient's prior incision and scar tissue was seen.A catheter could not be placed during this point of the procedure due to the eroded cylinder at the meatus, so the physician dissected down towards the corpora.At the time when the physician removed the cylinder components, they passed a flexible cystoscope into the meatus and into the left corpora which they noted distal scarring/erosion.All ipp implant device components were removed during the explant surgery, and there were no further patient complications reported.

• Brand Name: AMS 700 CXR 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 ; 5086521217
• MDR Report Key: 24127213
• Report Number: 2124215-2026-03772
• Device Sequence Number: 12145486
• Product Code: JCW
• UDI-Device Identifier: 00878953003757
• UDI-Public: (01)00878953003757(17)190322(10)169049007
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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 Expiration Date: 03/22/2019
• Device Model Number: 72404267
• Device Catalogue Number: 72404267
• Device Lot Number: 0169049007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2017
• 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: LOT: 178948018 UPN 72404155 RESERVOIR 65 ML PC IZ.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male