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

Model Number	72404230
Medical Device Problem Codes	Nonstandard Device (1420); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) required revision due to a tubing rupture between the pump and the right cylinder.A surgical procedure was performed in which the components were removed and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) required revision due to a tubing rupture between the pump and the right cylinder.A surgical procedure was performed in which the components were removed and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a detailed analysis.Both cylinder kink resistant tubing (krts) were microscopically examined and leak tested.The inspection revealed holes and leaks in both krts consistent with sharp instrument damage.Microscopic examination of the pump identified contamination with bodily fluid, and the krts on the pump were worn to the filament.The pump passed the leakage test.The spherical reservoir was also examined microscopically and showed wear at a fold in the reservoir shell, but it passed the leakage test.Based on the available information and analysis results, the sharp instrument damage was determined to be a secondary condition, and a definitive cause for the reported event could not be established.Therefore, a conclusion code of cause not established has been assigned.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) required revision due to a tubing rupture between the pump and the right cylinder.A surgical procedure was performed in which the components were removed and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a detailed analysis.Both cylinder kink resistant tubing (krts) were microscopically examined and leak tested.The inspection revealed holes and leaks in both krts consistent with sharp instrument damage.Microscopic examination of the pump identified contamination with bodily fluid, and the krts on the pump were worn to the filament.The pump passed the leakage test.The spherical reservoir was also examined microscopically and showed wear at a fold in the reservoir shell, but it passed the leakage test.Based on the available information and analysis results, the sharp instrument damage was determined to be a secondary condition, and a definitive cause for the reported event could not be established.Therefore, a conclusion code of cause not established has been assigned.

• 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: 22348795
• Report Number: 2124215-2025-41715
• Device Sequence Number: 20962273
• Product Code: JCW
• UDI-Device Identifier: 00878953003436
• UDI-Public: (01)00878953003436(17)150814(10)843456004
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted 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
• Report Date (Section B): 03/02/2026

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: 08/14/2015
• Device Model Number: 72404230
• Device Catalogue Number: 72404230
• Device Lot Number: 843456004
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 09/25/2025; 02/04/2026
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 10/21/2025; 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2013
• 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: 889693013.; RESERVOIR: UPN: 72404155 LOT: 889693013.; RESERVOIR: UPN: 72404155 LOT: 889693013.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown