MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC

Model Number 72404257

Device Problems Malposition of Device (2616); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2023

Event Type  Injury  

Manufacturer Narrative

The device is not available for analysis; therefore, no physical or visual 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; a conclusion code of cause not established was assigned to this investigation.

Event Description

It was reported that patient with this inflatable penile prosthesis experienced unsatisfied as the device had crossover distally, one of the cylinders was not in the right location and the reservoir was herniating.The device was replaced.There were no patient complications reported.

Event Description

It was reported that patient with this inflatable penile prosthesis experienced unsatisfied as the device had crossover distally, one of the cylinders was not placed in the right location and the reservoir was herniating.The device was replaced.There were no patient complications reported.

Manufacturer Narrative

B5.Describe event or problem updated there was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported event could not be confirmed.Based on the analysis results, an investigation conclusion code of unintended use error caused or contributed to event was assigned to this investigation.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• 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: 18432641
• MDR Text Key: 331859073
• Report Number: 2124215-2023-74838
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003658
• UDI-Public: 00878953003658
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 72404257
• Device Catalogue Number: 72404257
• Device Lot Number: 1100219036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: RESERVOIR: 720185-01/1100205860; RESERVOIR: 720185-01/1100205860
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR