MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 CX MS Pump; prosthesis, penis, inflatable

Model Number	72404232-10
Medical Device Problem Codes	Collapse (1099); Inflation Problem (1310); Mechanical Problem (1384); Migration (4003); Air/Gas in Device (4062)
Health Effect - Clinical Codes	Erosion (1750); Capsular Contracture (1761)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) pump was not functioning properly and that the device was exhibited inflation issues.A surgical procedure was performed, during which a large air bubble was identified within the original pump.Additionally, the pump was found to be inverted and encapsulated by surrounding tissue.Erosion was also observed.The pump was removed, and the air was evacuated from the system.A new pump was implanted, and the reservoir was refilled with fresh saline.The new pump was connected to the existing system and tested multiple times, demonstrating satisfactory function.No additional patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 720185-01 serial number: n/a batch/lot number: 1100353611 model/catalog description: reservoir flat iz 100 ml unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) pump was not functioning properly and exhibited inflation issues.The patient reported that the pump bulb remained flat and that the device could not be easily inflated or deflated.A surgical revision procedure was performed, during which a large air bubble was identified within the original pump.No holes or other visible damage were observed.The pump was also found to be inverted within the scrotum and encapsulated by surrounding tissue.In addition, erosion associated with the pump was identified in the scrotum.According to the physician, the inverted position of the pump may have contributed to the patient's difficulty operating the device, and the device was believed to have caused or contributed to the erosion.During the procedure, the pump was removed, and the air was evacuated from the system.A new pump was implanted, and the reservoir was refilled with fresh saline.The new pump was connected to the existing system and tested multiple times, demonstrating satisfactory function.No additional patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 720185-01.Serial number: n/a.Batch/lot number: 1100353611.Model/catalog description: reservoir flat iz 100 ml.Unique identifier (udi) #: (b)(4).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 device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.The reported patient symptoms are known risk associated with this device type and indicated as such in the instructions for use.A risk review was completed and confirmed that the events of fibrosis capsule formation, erosion, difficult to inflate, air, material or inadequate fluid within implanted device component limiting intended device function, mechanical malfunction/revision due to mechanical malfunction and migration 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 information available and analysis results, the reported clinical observation of pump air in system/component, pump mechanical issue, pump migration could not be confirmed.Therefore, a conclusion code of caused not established was assigned to this investigation.

• 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: 25707127
• Report Number: 2124215-2026-35835
• Device Sequence Number: 12041756
• Product Code: JCW
• UDI-Device Identifier: 00878953009780
• UDI-Public: (01)00878953009780(17)250927(10)1100367874
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/19/2026

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: 09/27/2025
• Device Model Number: 72404232-10
• Device Catalogue Number: 72404232-10
• Device Lot Number: 1100367874
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/03/2026
• Supplement Report FDA Received Date: 08/19/2026; 09/04/2026
• Date Device Manufactured: 09/28/2023
• 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: 84 YR
• Patient Sex: Male