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

Model Number	72018201
Medical Device Problem Codes	Deflation Problem (1149); Fluid/Blood Leak (1250); Inflation Problem (1310)
Health Effect - Clinical Codes	Discomfort (2330); Swelling/ Edema (4577)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) experienced discomfort and a spontaneous increase in volume on the right penoscrotal side, without any identifiable cause.The patient consulted a urologist, who prescribed antibiotics and anti-inflammatory medication.Later, the patient attempted to activate the prosthesis but was unsuccessful.Upon follow-up, the physician confirmed that the device could neither be inflated nor deflated.Magnetic resonance imaging (mri) revealed no fluid in the reservoir due a leak from some connection.The device remains implanted, and revision surgery is planned.No further patient complications have been reported.
Additional Manufacturer Narrative
D4.Concomitant product udi for pump and cylinder is (b)(4).
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) experienced discomfort and a spontaneous increase in volume on the right penoscrotal side, without any identifiable cause.The patient consulted a urologist, who prescribed antibiotics and anti-inflammatory medication.Later, the patient attempted to activate the prosthesis but was unsuccessful.Upon follow-up, the physician confirmed that the device could neither be inflated nor deflated.Magnetic resonance imaging (mri) revealed no fluid in the reservoir due a leak from some connection.As a result, the device was explanted and replaced.No further patient complications have been reported.
Additional Manufacturer Narrative
D4.Concomitant product udi for pump and cylinder is (b)(4).
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) experienced discomfort and a spontaneous increase in volume on the right penoscrotal side, without any identifiable cause.The patient consulted a urologist, who prescribed antibiotics and anti-inflammatory medication.Later, the patient attempted to activate the prosthesis but was unsuccessful.Upon follow-up, the physician confirmed that the device could neither be inflated nor deflated.Magnetic resonance imaging (mri) revealed no fluid in the reservoir due a leak from some connection.As a result, the device was explanted and replaced.No further patient complications have been reported.
Additional Manufacturer Narrative
D4.Concomitant product udi for pump and cylinder is (b)(4).Upon receipt at our quality assurance laboratory, this artificial urinary sphincter (aus) underwent a thorough analysis.The pump was visually inspected, functionally tested, and leak tested; visual inspection revealed internal contamination that prevented functional testing, and the pumps kink resistant tubing (krt) was worn down to the filament, though no leaks were identified.The cylinders were visually inspected and leak tested: the first cylinder had a hole at the krt adaptor junction consistent with sharp instrument damage, resulting in leakage, while the second cylinder had a hole from fatigue and a pinhole in the proximal end caused by a sharp instrument; after trimming the tubing for testing, the second cylinder passed the leak test.All four rear tip extenders passed visual inspection with no abnormalities.The reservoir was visually inspected, and leak tested with no anomalies observed, and a returned window quick connector also showed no abnormalities.The patient symptoms of discomfort and swelling were found to be listed in the ifu.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, the reported clinical observation of deflation issue, and inflation issue could not be confirmed; however, the cylinder not passing the leak test could affect product performance.Additionally, the allegation of a connector fluid leak was confirmed, as the cylinder tubing exhibited a fluid leak caused by fatigue.

• 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: 23538510
• Report Number: 2124215-2025-80656
• Device Sequence Number: 14678289
• Product Code: JCW
• UDI-Device Identifier: 00878953005676
• UDI-Public: (01)00878953005676(17)260509(10)1000566562
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 02/27/2026

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: 05/09/2026
• Device Model Number: 72018201
• Device Catalogue Number: 72018201
• Device Lot Number: 1000566562
• 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: 10/18/2025
• Supplement Date Received by Manufacturer: 12/16/2025; 02/04/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 01/07/2026; 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CYLINDERS AND PUMP: UPN 72404301/ LOT 1000569205; CYLINDERS AND PUMP: UPN 72404301/ LOT 1000569205; CYLINDERS AND PUMP: UPN 72404301/ LOT 1000569205
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Age: 50 YR
• Patient Sex: Male