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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
Device Problems Deflation Problem (1149); Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/19/2021
Event Type  Injury  
Event Description
It was reported that the patient is requesting a revision of an inflatable penile prosthesis(ipp) after having a previous replacement.The patient had an ipp previously replaced after the device had a stuck valve and inflation issues.Now, on his second ipp, the device has a stuck valve again with air in the system.The patient initially preferred to keep the prosthesis fully inflated instead of a revision.However a week ago, the valve spontaneously opened and deflated the prosthesis and the patient now is requesting a replacement of the device.
 
Event Description
It was reported that the patient is requesting a revision of an inflatable penile prosthesis (ipp) after having a previous replacement.The patient had an ipp previously replaced after the device had a stuck valve and inflation issues.Now, on his second ipp, the device has a stuck valve again with air in the system.The patient initially preferred to keep the prosthesis fully inflated instead of a revision.However a week ago, the valve spontaneously opened and deflated the prosthesis.The patient had a surgery to replace the ipp on 13may2021.
 
Manufacturer Narrative
Investigation summary: based on the information available, product analysis was able to confirm the reported event.Device history record (dhr): the lot information was not provided for the returned components so a device history record (dhr) review could not performed.Device technical analysis: the ams700 momentary squeeze (ms) pump was leak tested, visually inspected, examined using a microscope, and functionally tested.The pump kink resistant tubing (krt) was worn down to filament.The pump was functionally tested and failed the 8lb.Activation test (2).The activation test 2 verifies that with the pump in the deactive state, fluid does move from the reservoir side of the pump to the cylinder side of the pump through a squeezing motion of the pump bulb at less than 8 lb-f (pound-force) with no back pressure on the cylinder to the pump.The pump therefore required more than 8lbs.Of force to activate.The ams700 ipp flat reservoir was visually inspected, leak tested and examined using a microscope.The reservoir has fatigue and wear at folds in the reservoir shell; no leak was found in the reservoir shell.The ams700 ipp cylinders were visually inspected, leak tested, pressure tested and examined using a microscope.Both cylinders had wear at folds in cylinder bodies.Cylinder 1 has broken/detached in the outer tube that was result of wear at fold and broken fabric threads in cylinder body, no damage to the inner tube.Both cylinders passed all tests performed.The identified pump failed functional test and cylinder has broken/detached in the outer tube that was result of wear at fold and broken fabric threads in cylinder body could affect the functionality of the device, as result of deflation issue and air in system/component issue.Labeling review: the device instructions for use (ifu) was reviewed.There is no objective evidence that the user did not properly handle or use the device according to the ifu.Additionally, the reported events do not contain an allegation against the labeling.Investigation conclusion: based on the information available, a conclusion code of cause traced to component failure 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
10700 bren road w
minnetonka MN 55343
MDR Report Key11233976
MDR Text Key228833227
Report Number2183959-2021-00152
Device Sequence Number1
Product Code FHW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 08/25/2021
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? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2021
Initial Date Manufacturer Received 01/19/2021
Initial Date FDA Received01/26/2021
Supplement Dates Manufacturer Received08/09/2021
Supplement Dates FDA Received08/25/2021
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
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