MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Conceal; prosthesis, penis, inflatable

Model Number	72018201
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant components: model number/catalog number: 72404293, serial number: n/a.Batch/lot number: 1000579498.Model/catalog description: lgx 18cm d4 unique identifier (udi): (b)(4).Model number/catalog number: 72404310, serial number: n/a.Batch/lot number: 1000585124.Model/catalog description: pump, d4 unique identifier (udi): (b)(4).The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not performing as expected.Two weeks later a revision surgery was performed, upon examination a hole in the reservoir was found.The reservoir and cylinders were removed and replaced, the reservoir that was kept in the patient was not removed and a new one was added to the system.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 ; +1(508)652-1217
• MDR Report Key: 24673680
• Report Number: 2124215-2026-15986
• Device Sequence Number: 13289062
• Product Code: JCW
• UDI-Device Identifier: 00878953005676
• UDI-Public: (01)00878953005676(17)240420(10)1000264750
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/20/2024
• Device Model Number: 72018201
• Device Catalogue Number: 72018201
• Device Lot Number: 1000264750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 08/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male