MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 CXR; PROSTHESIS, PENIS, INFLATABLE

Model Number	72404013
Medical Device Problem Codes	Collapse (1099); Inflation Problem (1310); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cylinders of an inflatable penile prosthesis (ipp) could not be inflated.Air was observed within the device, and the pump remained flat.Subsequently, a surgical procedure was performed to remove and replace the ipp.No complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404310.Serial number: n/a.Batch/lot number: 1000076790.Model/catalog description: pump ms.Unique identifier (udi) #: (b)(4).Model number/catalog number: 72404161.Serial number: n/a.Batch/lot number: 0176512005.Model/catalog description: reservoir 65ml pc.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.Incomplete inflation and air in the system are acknowledged within the directions for use (dfu) and are not related to off-label use or failure to follow instructions.A risk review was completed, and inflation issue and air in the system are defined in the risk documentation.This event type has been accounted for during product risk 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.

• Brand Name: AMS 700 CXR
• 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: 25015871
• Report Number: 2124215-2026-22697
• Device Sequence Number: 18555538
• Product Code: JCW
• UDI-Device Identifier: 00878953002705
• UDI-Public: (01)00878953002705(17)220807(10)183326010
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• 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
• Report Date (Section B): 04/28/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/07/2022
• Device Model Number: 72404013
• Device Catalogue Number: 72404013
• Device Lot Number: 0183326010
• 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: 04/01/2026
• Initial Report FDA Received Date: 04/28/2026
• Date Device Manufactured: 08/07/2017
• 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: 36 YR
• Patient Sex: Male
• Patient Weight: 69 KG