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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
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BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72404252-10
Device Problems Inflation Problem (1310); Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Discomfort (2330); No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Event Date 12/16/2020
Event Type  Injury  
Event Description
It was reported that the patient saw his physician who indicated the pump has failed and will no longer transferred fluid.He felt like there was fluid in the system but that the pump was nonfunctioning.The patient stated that he inflated the device last night and felt a pop and then had an immediate deflation of the device.Since that time he can not inflate the device.The patient attempted trouble shooting techniques including the reboot and valve reset to no avail.The patient indicated he would follow up with the physician who stated he would replace the device.
 
Event Description
It was reported that the patient saw his physician who indicated the pump has failed and will no longer transferred fluid.He felt like there was fluid in the system but that the pump was nonfunctioning.The patient stated that he inflated the device last night and felt a pop and then had an immediate deflation of the device.Since that time he can not inflate the device.The patient attempted trouble shooting techniques including the reboot and valve reset to no avail.The patient had the inflatable penile prosthesis replaced.
 
Manufacturer Narrative
The ams700 ipp cylinders were visually inspected and functionally tested; no leaks were found.The cylinders were pressure tested and performed within specification.Both cylinders had wear at fold in cylinder body.The ams 700 momentary squeeze (ms) pump was visually inspected.The kink resistant tubing (krt) was worn to the filament; however, no leaks were present.The poppet rod was identified to be misaligned inside pump.The pump was not functionally tested due to the poppet rod being misaligned.Product analysis confirmed the reported event.
 
Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes, based on analysis results, that the identified misaligned poppet rod could affect the functionality of the device resulting in the reported inflation issue and mechanical issues.Therefore, product analysis confirmed pump malfunction, but unable to confirm the reported allegation related to discomfort.Device history record review (dhr): the device history record review (dhr) confirmed that the device met all material, assembly and performance specifications.A risk review confirmed that the event is accounted for in the risk documentation.Device technical analysis: upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The ams700 ipp cylinders were visually inspected and functionally tested; no leaks were found.The cylinders were pressure tested and performed within specification.Both cylinders had wear at fold in cylinder body.The ams 700 momentary squeeze (ms) pump was visually inspected and functionally tested.The kink resistant tubing (krt) was worn to the filament; however, no leaks were present.The poppet rod was identified to be misaligned inside pump.The pump was functionally tested to confirm the functionality and failed during priming.The pump was unable to be functionally tested further.The identified misaligned poppet rod could affect the functionality of the device, as the reported of inflation issue and mechanical issue.Labeling review: a review of the ams 700 msp pump operating room manual was performed.As stated throughout the operating room manual ams 700 ms pump, do not squeeze the deflation button and the pump bulb at the same time.The misalignment or displacement of the poppet rod is indicative of simultaneous compression of the deflation button and pump bulb.Based on the statements provided throughout the orm, it can be concluded that a problem does not exist in the orm.Investigation conclusion: based on this investigation a clear probable cause for the event was established; therefore, the conclusion code of failure to follow instructions was chosen as the damage observed can be traced to the user not following the manufacturers instructions.The pump misaligned poppet rod was identified.This displacement or misalignment is indicative of simultaneous compression of the deflation button and the pump bulb.Excessive physical manipulation can damage internal components resulting in component separation or misalignment and subsequent loss of inflation and deflation capabilities.
 
Event Description
It was reported that the patient felt a popping sensation accompanied by immediate deflation of this inflatable penile prosthesis (ipp) while manipulating the device; it could not be successfully inflated afterward.The patient presented to their physician who indicated the pump component of the device was no longer functioning and did not appropriately transfer fluid from the reservoir.Troubleshooting techniques were performed but did not resolve the problem.Approximately 6 weeks later a surgical procedure was performed wherein the existing ipp was explanted and replaced.During the procedure it was observed that the valve was not working correctly as the bearing within was not moving as expected.It was further noted that the patient had previously complained of mild discomfort from the tubing and a tight scrotum due to positioning of the pump but declined any intervention.Following replacement of the device the patient noted a slight dorsal curvature but was satisfied with the device.No patient complications were reported.
 
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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
MDR Report Key11146772
MDR Text Key226013320
Report Number2183959-2020-06344
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953009810
UDI-Public00878953009810
Combination Product (y/n)N
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup
Report Date 08/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date12/01/2021
Device Model Number72404252-10
Device Catalogue Number72404252-10
Device Lot Number1000363329
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2021
Date Manufacturer Received07/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
RESERVOIR.MODEL# 720185-01.LOT# 1000348063.
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age44 YR
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