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

Model Number	72018201
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the pump of this inflatable penile prosthesis ipp was not functioning.The physician confirmed, through ultrasound and other examinations, that there was no fluid in the reservoir.The ipp was explanted and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for pump is (b)(4).Udi field (d4) concomitant product udi for cylinders is (b)(4).
Event or Problem Description
It was reported that the pump of this inflatable penile prosthesis (ipp) was not functioning.The physician confirmed, through ultrasound and other examinations, that there was no fluid in the reservoir.The ipp was explanted and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for pump is (b)(4).Udi field (d4) concomitant product udi for cylinders is (b)(4).
Event or Problem Description
It was reported that the pump of this inflatable penile prosthesis (ipp) was not functioning.The physician confirmed, through ultrasound and other examinations, that there was no fluid in the reservoir.The ipp was explanted and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for pump is (b)(4).Udi field (d4) concomitant product udi for cylinders is (b)(4).Upon receipt at the quality assurance laboratory, the returned components underwent a comprehensive evaluation.Microscope inspection revealed contamination (bodily fluid) within the ms pump, and leakage testing showed the ms pump only pumped water in/out through the reservoir kink resistant tubing (krt).Further microscopical inspection indicated both cylinders had a hole in the proximal end caused by a sharp instrument, exhibited wear at folds in the proximal and middle sections, and had leaks at the proximal end from sharp instrument damage.The flat reservoir was found to have a hole and wear at a fold in the shell, along with a leak at the corner of a fold in the reservoir shell.Based on the available information and analysis results, the allegation of fluid leak was most likely due to a leak at the corner of a fold in the reservoir shell; therefore, a conclusion code of cause traced to component failure was assigned to this investigation.

• 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: 22333126
• Report Number: 2124215-2025-42220
• Device Sequence Number: 21122165
• Product Code: JCW
• UDI-Device Identifier: 00878953005676
• UDI-Public: (01)00878953005676(17)240724(10)1000309184
• 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: 2020
• 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): 11/03/2025

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: 07/24/2024
• Device Model Number: 72018201
• Device Catalogue Number: 72018201
• Device Lot Number: 1000309184
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 08/18/2025; 10/10/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 09/12/2025; 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2019
• 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 UPN 72404013, LOT 1000400136.; CYLINDERS UPN 72404013, LOT 1000400136.; CYLINDERS UPN 72404013, LOT 1000400136.; PUMP UPN 72404310, LOT 1000412790.; PUMP UPN 72404310, LOT 1000412790.; PUMP UPN 72404310, LOT 1000412790.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 47 YR
• Patient Sex: Male