MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONCEAL; PROSTHESIS, PENIS, INFLATABLE

Model Number	72018201
Medical Device Problem Codes	Fluid/Blood Leak (1250); Nonstandard Device (1420); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the reservoir of this inflatable penile prosthesis (ipp) was leaking, and the device could not be used normally for erection.A surgical procedure was performed to remove and replace the reservoir.The cause of the fluid loss was a connection issue.No patient complications were reported.
Additional Manufacturer Narrative
Correction to field d6b: explant date.
Event or Problem Description
It was reported that the reservoir of this inflatable penile prosthesis (ipp) was leaking, and the device could not be used normally for erection.A surgical procedure was performed to remove and replace the reservoir.The cause of the fluid loss was a connection issue.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the reservoir of this inflatable penile prosthesis (ipp) underwent a thorough analysis.The reservoir was microscopically inspected and tested for leaks.Microscope examination revealed that the reservoir had wear at fold and a hole from wear in reservoir shell.The leakage test revealed a leak at the corner of a fold in the reservoir shell.Based on the information available and analysis results, the reason for the fluid leak was most likely determined to be the hole/leak at the corner of a fold in the reservoir.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 and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the reservoir of this inflatable penile prosthesis (ipp) was leaking, and the device could not be used normally for erection.A surgical procedure was performed to remove and replace the reservoir.The cause of the fluid loss was a connection issue.No patient complications were reported.

• Brand Name: CONCEAL
• 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: 23323364
• Report Number: 2124215-2025-74086
• Device Sequence Number: 9845711
• Product Code: JCW
• UDI-Device Identifier: 00878953005676
• UDI-Public: (01)00878953005676(17)260214(10)1000529052
• 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: 2022
• Device Explanted Year: 2025
• 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,Followup,Followup
• Report Date (Section B): 12/29/2025

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: 02/14/2026
• Device Model Number: 72018201
• Device Catalogue Number: 72018201
• Device Lot Number: 1000529052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 10/21/2025; 12/05/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 11/17/2025; 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2021
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 70 KG