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

Model Number	720185-01
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	07/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) exhibited auto inflation.A surgical procedure was performed, during which a capsular formation surrounding the reservoir was identified.The reservoir was laparoscopically released from the capsule, which resolved the auto inflation issue.Additionally, the patient requested replacement of the existing ms pump with a tenacio pump.As a result, the pump was exchanged for a tenacio pump during the same procedure.No additional patient complications were reported.
Additional Manufacturer Narrative
Concomitant product implanted at time of the event: model number/catalog number: 72404234-14, serial number: n/a, batch/lot number: 1100414275, model/catalog description: cx preconnect ms 24cm ps 14cm tl iz, unique identifier (udi): (b)(4).

• 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: 50360027
• Report Number: 2124215-2026-45015
• Device Sequence Number: 14962365
• Product Code: JCW
• UDI-Device Identifier: 00878953005669
• UDI-Public: (01)00878953005669(17)270106(10)1100651255
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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 Model Number: 720185-01
• Device Catalogue Number: 720185-01
• Device Lot Number: 1100651255
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 10/02/2026
• Date Device Manufactured: 01/06/2025
• 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: Male