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

Model Number	72018201
Medical Device Problem Codes	Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 unique identifier (udi) for lgx preconnect: (b)(4).
Event or Problem Description
It was reported that the reservoir of this inflatable penile prosthesis (ipp) presented a fluid loss.The ipp was explanted and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
D4 unique identifier (udi) for lgx preconnect: (b)(4).Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Both cylinders were microscopically inspected and had wear at a fold in the proximal end, middle, and distal end of the cylinder.Both cylinders passed the leak test.Momentary squeeze (ms) pump kink resistant tubing (krt) was microscopically inspected and were worn to the filament.The ms pump passed leak test and functional evaluation.The reservoir was microscopically inspected and tested for leaks.The component presented wear at a fold in its shell, and it did not pass the leakage test.Based on the information available and analysis results, the leak identified in the reservoir could have caused or contributed to the reported clinical observation of reservoir fluid loss.
Event or Problem Description
It was reported that the reservoir of this inflatable penile prosthesis (ipp) presented a fluid loss.The ipp was explanted and replaced.There were no patient complications 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: 21810625
• Report Number: 2124215-2025-21865
• Device Sequence Number: 7568458
• Product Code: JCW
• UDI-Device Identifier: 00878953005676
• UDI-Public: (01)00878953005676(17)290910(10)1100587543
• 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 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
• Report Date (Section B): 06/30/2025

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 Model Number: 72018201
• Device Catalogue Number: 72018201
• Device Lot Number: 1100587543
• 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: 03/20/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2024
• 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: CRX 15: UPN 72404301 LOT 1100584759.; CRX 15: UPN 72404301 LOT 1100584759.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male