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

Model Number	72404237
Medical Device Problem Codes	Collapse (1099); Fluid/Blood Leak (1250); Inflation Problem (1310); Nonstandard Device (1420)
Health Effect - Clinical Codes	Erosion (1750); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Detailed product information 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.The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) was not functioning properly.The cylinders are not filling, and the pump is persistently collapsing.As a result, the device was explanted.No additional information was provided.
Additional Manufacturer Narrative
Detailed product information 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.The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.The patient symptom is a known risk associated with this device type/procedure, and it is noted as such as in the instructions for use.
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) was not functioning properly.During the surgical procedure, it was observed that the cylinders were not filling, the pump was persistently collapsing, and fluid loss was present.An erosion was also identified.The ipp was explanted.No additional information was provided.
Additional Manufacturer Narrative
Detailed product information 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.Upon receipt at our quality assurance laboratory, the returned components underwent a thorough analysis.The first cylinder was subjected to microscopic inspection and leak testing; the microscopic inspection revealed a hole in the outer tube, broken fabric threads, and a hole in the inner tube due to kink resistant tubing (krt) wear at the proximal end, and the outer sleeve was also detached at the proximal end as a result of krt wear on the cylinder body; the leak test confirmed that the first cylinder exhibited leakage originating from krt wear in the proximal end.The second cylinder also underwent microscopic inspection and leak testing; microscopic examination showed wear at the fold in the proximal end, while the cylinder successfully passed the leak test with no leakage detected.The pump (ms pump) was evaluated through microscopic inspection and leak testing; microscopic observation revealed internal contamination consistent with bodily fluid, and although the pump passed the leak test, it was not functionally tested to avoid potential damage to the testing equipment.The device history record (dhr) review was unable to be performed as the lot number was not provided.The device instructions for use (ifu) was reviewed.The reported patient symptom of erosion was found to be listed in the ifu.A risk review was completed and confirmed that the event of "erosion", "mechanical malfunction (leaks, incomplete inflation/ deflation, kinking)", and "device has a fluid leak" were defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the available information and analysis results, the clinical observation of a collapsed/dimpled/flat pump could not be confirmed as the pump could not be functionally tested; however, the leak caused by krt wear in the first cylinder could have caused or contributed to the reported clinical observations of cylinder inflation issues and device fluid leakage.Therefore, the conclusion codes of cause traced to component failure and known inherent risk of device were assigned to this investigation.
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) was not functioning properly.During the surgical procedure, it was observed that the cylinders were not filling, the pump was persistently collapsing, and fluid loss was present.An erosion was also identified.The ipp was explanted.No additional information was provided.

• 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: 23425346
• Report Number: 2124215-2025-77068
• Device Sequence Number: 9863549
• Product Code: JCW
• UDI-Device Identifier: 00878953003504
• UDI-Public: (01)00878953003504
• Combination Product (Y/N): Y
• Initial Reporter Country: DR
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 03/06/2026

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 Model Number: 72404237
• Device Catalogue Number: 72404237
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: 12/31/2025; 02/06/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 01/22/2026; 03/06/2026
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male