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

Model Number	72404237
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384); Malposition of Device (2616); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient implanted with an inflatable penile prosthesis (ipp) experienced difficulty operating the pump and inadequate inflation of the device.A revision procedure was performed, during which the existing pump was explanted and replaced with a tenacio pump.The physician suspected that the reservoir placement and pump location may have contributed to the reported issue.The age of the device was also considered a contributing factor.No patient complications were reported.
Event or Problem Description
It was reported that the patient implanted with this inflatable penile prosthesis (ipp) experienced difficulty operating the pump and was dissatisfied.As a result, a surgical revision procedure was performed to replace with tenacio pump.No patient complications were reported.
Additional Manufacturer Narrative
Correction to field b1: adverse event/product problem.Model number/catalog number: 72404155.Serial number: n/a.Batch/lot number: 1100319281.Model/catalog description: reservoir 65 ml pc/iz.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.A risk review was completed and confirmed that the events of mechanical malfunction/revision due to mechanical malfunction and patient dissatisfaction (with length, ability to use and nonspecific reasons) 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 the cause that contributed to the reported event cannot be established.Therefore, a conclusion code of cause not established was assigned to this investigation.
Additional Manufacturer Narrative
Model number/catalog number: 72404155 serial number: n/a batch/lot number: 1100319281 model/catalog description: reservoir 65 ml pc/iz unique identifier (udi) #: (b)(4).

• 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: 50176963
• Report Number: 2124215-2026-42447
• Device Sequence Number: 18210497
• Product Code: JCW
• UDI-Device Identifier: 00878953003504
• UDI-Public: (01)00878953003504(17)250601(10)1100310674
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 08/07/2026

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: 06/01/2025
• Device Model Number: 72404237
• Device Catalogue Number: 72404237
• Device Lot Number: 1100310674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 06/02/2023
• 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: 72 YR
• Patient Sex: Male