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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
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BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72404012
Device Problems Material Discolored (1170); Fluid/Blood Leak (1250); Mechanical Problem (1384); Inadequacy of Device Shape and/or Size (1583); Connection Problem (2900); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 12/08/2022
Event Type  Injury  
Event Description
It was reported that the patient with this inflatable penile prosthesis experienced pain in the penis eight week after the implant procedure, when the first pump compression was performed.Two months later, the patient noted that the pump could not be pressed after 3-4 times and there was not fluid in it.Nine months later, an ultrasound was performed, and it was found that there was a total fluid loss from the reservoir and the cylinder was kinked at the front end.The patient underwent a revision surgery, during which it was identified that the tube between the pump and the reservoir was disconnected, and the size of the cylinders were not the correct one for the patient.All components were removed and replaced.There were no further patient complications reported.
 
Manufacturer Narrative
Corrected h6: device code.There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported clinical observations of "cosmetic/appearance problem", "size incorrect for patient" and "pain" were determined to be inadvertent/unintentional interaction; therefore, a conclusion code of unintended use error caused or contributed to event was assigned to this investigation.
 
Event Description
It was reported that the patient with this inflatable penile prosthesis experienced pain in the penis eight week after the implant procedure, when the first pump compression was performed.Two months later, the patient noted that the pump could not be pressed after 3-4 times and there was not fluid in it.Nine months later, an ultrasound was performed, and it was found that there was a total fluid loss from the reservoir and the cylinder was kinked at the front end.The patient underwent a revision surgery, during which it was identified that the tube between the pump and the reservoir was disconnected, and the size of the cylinders were not the correct one for the patient.All components were removed and replaced.There were no further patient complications reported.
 
Event Description
It was reported that the patient with this inflatable penile prosthesis experienced pain in the penis eight week after the implant procedure, when the first pump compression was performed.Two months later, the patient noted that the pump could not be pressed after 3-4 times and there was not fluid in it.Nine months later, an ultrasound was performed, and it was found that there was a total fluid loss from the reservoir and the cylinder was kinked at the front end.The patient underwent a revision surgery, during which it was identified that the tube between the pump and the reservoir was disconnected, and the size of the cylinders were not the correct one for the patient.All components were removed and replaced.There were no further patient complications reported.
 
Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.Both cylinders were microscopically inspected, and leak tested.The first cylinder had buckling at folds in the proximal end and middle of its body.In addition, the kink resistant tubing (krt) of the cylinder presented a hole from wear.This cylinder did not pass the leakage test.The second cylinder presented wear at a fold in the proximal end and middle of the body and a hole in its distal end, consistent with sharp instrument damage.This cylinder did not pass the leakage test due to the distal damage, likely sustained at during explant surgery.The pump was microscopically inspected, and leak tested.Microscopic evaluation revealed bodily contamination within the component; due to that finding, the pump was not functionally tested.No leaks were identified in the pump.The reservoir was microscopically inspected, and leak tested.The reservoir had wear at a fold in its shell.No leaks were identified in the component.The reported patient symptom of pain is a known risk associated with implant of these devices as indicated in the instructions for use.The reported clinical observations of "cosmetic/appearance problem", "size incorrect for patient" and "pain" were determined to be inadvertent/unintentional interaction; therefore, a conclusion code of unintended use error caused or contributed to event was assigned to this investigation.
 
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Brand Name
AMS INFLATABLE PENILE PROSTHESIS
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 Key18096537
MDR Text Key327676424
Report Number2124215-2023-62853
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953002699
UDI-Public00878953002699
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 01/09/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number72404012
Device Catalogue Number72404012
Device Lot Number1100079012
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/02/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/02/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
PUMP: UPN: 72404310 / LOT: 1100141475; PUMP: UPN: 72404310 / LOT: 1100141475; PUMP: UPN: 72404310 / LOT: 1100141475; RESERVOIR: UPN: 72404161 / LOT: 1000337768; RESERVOIR: UPN: 72404161 / LOT: 1000337768; RESERVOIR: UPN: 72404161 / LOT: 1000337768
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age58 YR
Patient SexMale
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