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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 72404232-10
Device Problem Difficult or Delayed Activation (2577)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/30/2020
Event Type  Injury  
Event Description
It was reported that the patient will have a revision of an inflatable penile prosthesis(ipp) pump due to the pump not working at activation.No patient complications were reported.
 
Event Description
It was reported that the patient had a revision of an inflatable penile prosthesis(ipp) pump due to the pump not working at activation.No patient complications were reported.
 
Manufacturer Narrative
Investigation summary: an allegation related to pump failed to activate was reported.Product analysis concluded these activation issues could affect the functionality of the pump.Device technical analysis: the ams 700 momentary squeeze (ms) pump was visually inspected and functionally tested; no leaks were found.The pump was functionally tested and failed the 8lb.Activation test.The pump therefore required more than 8lbs.Of force to activate.Product analysis concluded these activation issues could affect the functionality of the pump.Product analysis confirmed pump malfunction.Device history record (dhr): review of manufacturing documentation was performed to ensure that all required in-process and final inspections and testing were completed.Review of the manufacturing records for batch 1000300231 found no evidence that the device failed to meet applicable product specifications prior to shipment from boston scientific.Labeling review: there is no objective evidence that the user did not properly handle or use the device according to the ifu, ams700 ms pump.Additionally, the reported events do not contain an allegation against the labeling.Conclusion: based on this investigation, the investigation conclusion code of cause traced to component failure was chosen because the reported events could be traced to a component failure.
 
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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
10700 bren road w
minnetonka MN 55343
MDR Report Key11168670
MDR Text Key226770475
Report Number2183959-2021-00046
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953009780
UDI-Public00878953009780
Combination Product (y/n)N
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 03/09/2021
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
Device Expiration Date07/08/2021
Device Model Number72404232-10
Device Catalogue Number72404232-10
Device Lot Number1000300231
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/24/2021
Initial Date Manufacturer Received 12/30/2020
Initial Date FDA Received01/14/2021
Supplement Dates Manufacturer Received02/16/2021
Supplement Dates FDA Received03/09/2021
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age68 YR
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