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

Model Number	72018201
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an inflatable penile prosthesis (ipp) was implanted in (b)(6) 2024, then, in (b)(6) 2024, it was found that the pump was difficult to press.After this, in (b)(6) 2024, it was found that the pump did not rebound after pressing, and later tests did not rebound.Finally, during a surgical procedure in 2025, it was determined the device connection was intact and there was water in the balloon, but the pump did not rebound at all, so it was replaced.There were no further patient complications.
Additional Manufacturer Narrative
Upon receipt of this inflatable penile prosthesis at our quality assurance laboratory, this device was thoroughly analyzed.Microscopic analysis identified the reservoir krt (kink resistant tubing) tubing at the strain relief appeared crushed/flattened by tool damage, it did not leak, passing the leakage test.Both cylinders were also analyzed; the analysis of the first cylinder detected it had a hole in the proximal end of the cylinder from sharp instrument, this cylinder had wear at fold in the proximal end, middle, and distal end of the cylinder.The second cylinder had wear at fold in the proximal end, middle, and distal end of the cylinder.The cylinders were tested too.The leakage test for first cylinder informed it had a leak from sharp instrument in the proximal end of the cylinder.The second cylinder successfully passed leakage test.The reported allegation of mechanical issue was not confirmed.Based on the information provided, cause not established was selected as the most probable cause for the complaint.
Event or Problem Description
It was reported that an inflatable penile prosthesis (ipp) was implanted in may 2024, then, in july, it was found that the pump was difficult to press.After this, in december, it was found that the pump did not rebound after pressing, and later tests did not rebound.Finally, during a surgical procedure in 2025, it was determined the device connection was intact and there was water in the ballon, but the pump did not rebound at all, so it was replaced.There were no further patient complications.

• 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: 21701547
• Report Number: 2124215-2025-18767
• Device Sequence Number: 8636530
• Product Code: JCW
• UDI-Device Identifier: 00878953005676
• UDI-Public: (01)00878953005676(17)281002(10)1100369794
• 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: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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: 1100369794
• 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: 03/14/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2023
• 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: 33 YR
• Patient Sex: Male