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

Model Number	72404263
Medical Device Problem Codes	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	05/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) revision surgery due to a rupture in the left cylinder.The components were removed and replaced no patient complications were reported.
Event or Problem Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) revision surgery due to a rupture in the left cylinder.The components were removed and replaced no patient complications were reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).Correction to field c2/d10: concomitant product/therapy.Correction to field g2: report source.Upon receipt at our quality assurance laboratory, the cylinders and pump of this inflatable penile prosthesis (ipp) underwent a thorough analysis.Both cylinders were microscopically inspected and tested for leaks.Microscope examination revealed that the first cylinder had a hole in the outer tube from bulge rupture in the proximal end of the cylinder.The first cylinder had wear at fold in the proximal end, middle, and distal end of the cylinder.The first cylinder had a leak from a bulge in the proximal end of the cylinder when inflated with syringe.The second cylinder had wear at fold in the proximal end, middle, and distal end of the cylinder.The second cylinder had wear on the outer tube from a buckling fold in the proximal end.No leaks were found in the second cylinder.The pump was microscopically inspected, leak and functionally tested.The pump passed the visual inspection.No damage or abnormalities were found.No leaks were found.The pump passed the functional testing.Based on the information available and analysis results, the reason for the hole/perforation was most likely determined to be a leak/rupture from bulge in the first cylinder; therefore, a conclusion code of cause traced to component failure was assigned to this investigation.

• 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
• MDR Report Key: 22328543
• Report Number: 2124215-2025-41804
• Device Sequence Number: 8289052
• Product Code: JCW
• UDI-Device Identifier: 00878953003719
• UDI-Public: (01)00878953003719(17)180610(10)137476004
• 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 Implanted Year: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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: 06/10/2018
• Device Model Number: 72404263
• Device Catalogue Number: 72404263
• Device Lot Number: 0137476004
• 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
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 138389018.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown