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

Model Number	720185-01
Medical Device Problem Codes	Inflation Problem (1310); Malposition of Device (2616); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 72404232-10.Serial number: n/a.Batch/lot number: 1100556230.Model/catalog description: cx preconnect ms 18cm ps 10cm tl iz.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.The migration is a known risk associated with this device type/procedure, and it is noted as such as in the instructions for use.Based on the information available, the conclusion codes of caused not established and known inherent risk of device were assigned to this investigation.
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) exhibited auto inflation issues.Imaging was obtained and revealed that the reservoir was folded over itself, potentially causing excess pressure within the system.A surgical procedure was performed during which the conceal reservoir was explanted and a 65 cc spherical reservoir was implanted.No patient complications were reported.
Additional Manufacturer Narrative
Correction to field b1: adverse event/product problem, b5: describe event or problem, f10: device codes and h6: device codes.Model number/catalog number: 72404232-10.Serial number: n/a.Batch/lot number: 1100556230.Model/catalog description: cx preconnect ms 18cm ps 10cm tl iz.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.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.Risk review was completed and confirmed that the events of device malposition and spontaneous inflation leading to altered therapeutic response were defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the information available and analysis results, the reported clinical observation of device spontaneous inflation and reservoir malposition of device, could not be confirmed.Therefore, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) exhibited auto inflation issues.Imaging was obtained and revealed that the reservoir was folded over itself due to a malposition, potentially causing excess pressure within the system.A surgical procedure was performed during which the conceal reservoir was explanted and a 65 cc spherical reservoir was implanted.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
• MDR Report Key: 25020802
• Report Number: 2124215-2026-22901
• Device Sequence Number: 13361945
• Product Code: JCW
• UDI-Device Identifier: 00878953005669
• UDI-Public: (01)00878953005669(17)261018(10)1100611065
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2026

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 Model Number: 720185-01
• Device Catalogue Number: 720185-01
• Device Lot Number: 1100611065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 06/03/2026
• Date Device Manufactured: 10/18/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Unknown