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

Model Number	72404263
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cylinders of this inflatable penile prosthesis (ipp) did not inflate.A surgical procedure was performed, during which a defect in the tubing between the pump and cylinders was identified; therefore, the existing ipp was removed and replaced.No patient complications were reported.
Event or Problem Description
It was reported that the cylinders of this inflatable penile prosthesis (ipp) did not inflate.A surgical procedure was performed, during which a defect in the tubing between the pump and cylinders was identified; therefore, the existing ipp was removed and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The cylinders were microscopically inspected, leak tested.Microscope examination revealed that both cylinders had a hole in the outer tube from sharp instrument damage/ tool marks in the middle of the cylinder.Both cylinders had wear at fold in the proximal end, middle, and distal end of the cylinder.Both cylinders passed the leakage test.The pump was microscopically inspected, leak and functionally tested.Microscope examination revealed that the poppet rod was found to be misaligned in the pump.Leakage test revealed that the pump pumped water opposite of how it should usually flow due to the misalignment of the poppet rod.To avoid damaging the test equipment, the pump was not functionally tested.The reservoir was microscopically inspected, and leak tested.Microscope examination revealed that reservoir had wear at a fold in reservoir shell.Reservoir passed the leakage test.Based on the information available and analysis results, the reason for the mechanical issue and the inflation issue was most likely determined to be the pump misaligned poppet rod from the functional test performed.Therefore, a conclusion code of cause traced to component failure was assigned to this investigation.Detailed product information for the reservoir was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.

• 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: 21232534
• Report Number: 2124215-2025-03267
• Device Sequence Number: 4287275
• Product Code: JCW
• UDI-Device Identifier: 00878953003719
• UDI-Public: (01)00878953003719(17)250803(10)1100339056
• Combination Product (Y/N): Y
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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: 08/03/2025
• Device Model Number: 72404263
• Device Catalogue Number: 72404263
• Device Lot Number: 1100339056
• 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: 01/03/2025
• Supplement Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2023
• 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: Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male