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

Model Number	72404237
Medical Device Problem Codes	Collapse (1099); Inflation Problem (1310); Nonstandard Device (1420); Material Deformation (2976)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	12/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced pain, discomfort, and dissatisfaction due to the device not inflating properly.The physician reported that the pump bulb remained collapsed and did not allow satisfactory inflation of the prosthesis.Troubleshooting maneuvers were attempted without resolution.The physician believed that this mechanical issue may have contributed to the patients pain and discomfort.The option of a revision or replacement surgery will be evaluated.There were no further patient complications reported.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced pain, discomfort, and dissatisfaction due to the device not inflating properly.The physician reported that the pump bulb remained collapsed and did not allow satisfactory inflation of the prosthesis.Troubleshooting maneuvers were attempted without resolution.The physician believed that this mechanical issue may have contributed to the pain and discomfort of the patient.The option of a revision or replacement surgery will be evaluated.There were no further patient complications reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (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.Based on the information available the cause that contributed to the reported event cannot be established, so a conclusion code of unable to exclude device problem was assigned to this investigation.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced pain, discomfort, and dissatisfaction due to the device not inflating properly.The physician reported that the pump bulb remained collapsed and did not allow satisfactory inflation of the prosthesis, and troubleshooting maneuvers were attempted without resolution.A surgical procedure was performed in which a kink in the tubing connecting the reservoir to the pump was identified, which prevented fluid flow between the components.The reservoir was repositioned, the tubing was trimmed, and the system was reconnected.There were no further patient complications reported.
Additional Manufacturer Narrative
Model number/catalog number: 720185-01.Serial number: n/a.Batch/lot number: 1100746479.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.A risk review was completed and confirmed that the event of discomfort, pain, device operates differently than expected, inflation issue and collapsed/dimpled/ flat was 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, so a conclusion code of unable to exclude device problem 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: 24117377
• Report Number: 2124215-2026-03578
• Device Sequence Number: 5987190
• Product Code: JCW
• Combination Product (Y/N): Y
• Initial Reporter Country: MX
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/28/2026

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: 08/28/2026
• Device Model Number: 72404237
• Device Catalogue Number: 72404237
• Device Lot Number: 1100577892
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 02/03/2026; 03/17/2026; 07/30/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 02/27/2026; 04/14/2026; 08/28/2026
• Date Device Manufactured: 08/27/2024
• 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: 720185-01 / LOT: 1100746479; RESERVOIR: UPN: 720185-01 / LOT: 1100746479
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 39 YR
• Patient Sex: Male