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

Model Number	720185-01
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Mechanical Problem (1384); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an inflatable penile prosthesis (ipp) was not fully inflating, resulting in a sticky pump.Upon revision, it was found that the tubing at the reservoir head was broken and partially detached, which was suspected to be the cause of the device's inability to fully inflate and fluid loss.As a result, the device was removed and replaced.The tenacio pump was replaced with an ms pump because the patient found it difficult to operate.No patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404432.Serial number: n/a.Batch/lot number: 1100735269.Model/catalog description: cx preconnect tenacio 18cm ps, 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: 50553498
• Report Number: 2124215-2026-46677
• Device Sequence Number: 18737900
• Product Code: JCW
• UDI-Device Identifier: 00878953005669
• UDI-Public: (01)00878953005669(17)280121(10)1100878705
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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: 1100878705
• 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: 08/06/2026
• Initial Report FDA Received Date: 09/01/2026
• Date Device Manufactured: 01/21/2026
• 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: 70 YR
• Patient Sex: Male