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

Model Number 72404233-12

Device Problem Deflation Problem (1149)

Patient Problem Pain (1994)

Event Date 12/01/2023

Event Type  Injury  

Event Description

It was reported that the patient with this inflatable penile prosthesis was unable to deflate the cylinders and experienced pain.The patient service specialist discussed proper deflation techniques with the patient and emailed him post operative resources.The patient will be contacting the physician for device evaluation.Boston scientific has been unable to obtain additional information despite good faith efforts.

Manufacturer Narrative

B3.Exact date of event is unknown.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.

• 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: 18531151
• MDR Text Key: 333088050
• Report Number: 2124215-2024-02241
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953009797
• UDI-Public: 00878953009797
• 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: Other
• Type of Report: Initial
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 72404233-12
• Device Catalogue Number: 72404233-12
• Device Lot Number: 1100345036
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2023
• 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: REAR TIP EXTENDER (LEFT): 72404330/1100348620.; REAR TIP EXTENDER (RIGHT): 72404322/1100362869.; RESERVOIR: 720185-01/1100379152.
• Patient Outcome(s): Other
• Patient Sex: Male