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

Model Number 72404257

Device Problems Deflation Problem (1149); Inflation Problem (1310); Mechanical Problem (1384); Device Contamination with Chemical or Other Material (2944); Adverse Event Without Identified Device or Use Problem (2993); Air/Gas in Device (4062)

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

Event Date 06/13/2023

Event Type  Injury  

Event Description

It was reported that this inflatable penile prosthesis (ipp) was not functioning as intended.A surgical procedure was performed during which it was noted that there was air in the pump, the device did not inflate or deflate, and there was foreign material present the reservoir.The medical staff removed the foreign material and withdrew the fluid from the reservoir; however, the pump still did not work properly.All components from the existing device were removed and replaced with a new ipp.There were no patient complications reported.

Manufacturer Narrative

Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.Both cylinders were visually inspected, and leak tested.Visual examination revealed that both cylinders had wear at fold in the middle of their body and their kink resistant tubings (krt) were worn to the filament.No leaks were identified in the cylinders.The pump was visually inspected, leak tested, and functionally tested.During visual test, it was noted that the krt was worn to the filament, cut into two pieces and had kinked/twisted in the tubing.No leaks were identified; however, the pump did not pass the functional test.The reservoir was visually inspected, and leak tested.No damage or abnormalities were noted, no leaks were identified in the reservoir.Based on the information available and analysis results, the pump not passing the functional test could have caused or contributed to the reported clinical observations; therefore, a conclusion code of caused traced to component failure was assigned to this investigation.

Event Description

It was reported that the patient could not get this inflatable penile prosthesis (ipp) to work.A surgical procedure was performed during which it was noted that there was air in the pump, the device did not inflate or deflate, and there was a foreign material present the reservoir.The medical staff removed the foreign material and withdrew the fluid from the reservoir; however, the pump still did not work properly.Therefore, all components from the existing device were removed and replaced with a new ipp.There were no patient compo cations reported.

Manufacturer Narrative

Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.Both cylinders were visually inspected, and leak tested.Visual examination revealed that both cylinders had wear at fold in the middle of their body and their kink resistant tubings (krt) were worn to the filament.No leaks were identified in the cylinders.The pump was visually inspected, leak tested, and functionally tested.During visual test, it was noted that the krt was worn to the filament, cut into two pieces and had kinked/twisted in the tubing; in addition, the deflation ball was misaligned.No leaks were identified; however, the pump did not pass the functional test.The reservoir was visually inspected, and leak tested.No damage or abnormalities were noted, no leaks were identified in the reservoir.Based on the information available and analysis results, the pump not passing the functional test could have caused or contributed to the reported clinical observations.

Event Description

It was reported that the patient could not get this inflatable penile prosthesis (ipp) to work.A surgical procedure was performed during which it was noted that there was air in the pump, the device did not inflate or deflate, and there was a foreign material present the reservoir.The medical staff removed the foreign material and withdrew the fluid from the reservoir; however, the pump still did not work properly.Therefore, all components from the existing device were removed and replaced with a new ipp.There were no patient complications reported.

• 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: 17257545
• MDR Text Key: 318440864
• Report Number: 2124215-2023-34666
• 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,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male