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

Model Number	72404283
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis ipp presented with a nonfunctioning pump.A revision surgery was performed, during which the physician confirmed that manual manipulation was attempted but unsuccessful.The device was explanted and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Udi field (d4) 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.Mechanical issue is acknowledged within the dfu and is not related to off-label use or failure to follow instructions.Additionally, it is concluded that the cause of the allegation cannot be established without product return.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with a nonfunctioning pump.A revision surgery was performed, during which the physician confirmed that manual manipulation was attempted but unsuccessful.The device was explanted and replaced.No patient complications were reported.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with a nonfunctioning pump.A revision surgery was performed, during which the physician confirmed that manual manipulation was attempted but unsuccessful.The device was explanted and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72018201 serial number: n/a batch/lot number: 1100341635 model/catalog description: reservoir flat 100 ml unique identifier (udi) #: (b)(4).Correction to field b1: adverse event/product problem 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.Mechanical issue is acknowledged within the instructions for use (ifu) and is not related to off-label use or failure to follow instructions.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.

• 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: 22698087
• Report Number: 2124215-2025-53436
• Device Sequence Number: 8878925
• Product Code: JCW
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 06/02/2026

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 Expiration Date: 03/18/2025
• Device Model Number: 72404283
• Device Catalogue Number: 72404283
• Device Lot Number: 1000414048
• 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: 07/12/2025
• Supplement Date Received by Manufacturer: 01/29/2026; 05/05/2026
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 02/23/2026; 06/02/2026
• Date Device Manufactured: 03/19/2020
• 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 LOT 1100341635, UPN 72018201; RESERVOIR LOT 1100341635, UPN 72018201
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male