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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
Device Problems Collapse; Inflation Problem
Event Date 07/07/2019
Event Type  Malfunction  
Manufacturer Narrative

Model number/catalog number: 72404155, serial number null batch/lot number: (b)(4), model/catalog description: reservoir 65 ml pc/iz.

 
Event Description

It was reported that the patient indicated experiencing inflation issues with an 8 year old inflatable penile prosthesis (ipp). The patient noticed that the cylinders were "severely deflated" and when the patient tried to activate the device, the pump would deflate and not allow any further pumping. It was also expressed that clicking the release button, and squeezing the sides of the pump worked in refilling it, however that was "all it appeared to be doing". The patient also mentioned attempting both pumping methods several times with no results. Patient liaison was contacted and it was recommended to schedule an appointment for assessment. Product performance analyst (ppa) was unable to request further information, as customer contact for the account is unknown. No more information available at the moment. Should additional information become available, it will be provided. Additional information was received in which it was reported that the patient had an ultrasound completed. In the ultrasound it was determined that the reservoir was over half empty of fluid. No more information available at the moment. Should additional information become available, it will be provided.

 
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Brand NameAMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
Type of DeviceDEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
Manufacturer Contact
alyson harris
10700 bren road w
minnetonka , MN 55343
4083953452
MDR Report Key8843137
Report Number2183959-2019-65393
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type CONSUMER
Type of Report Initial
Report Date 07/30/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/30/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/20/2013
Device MODEL Number72404232
Device Catalogue Number72404232
Device LOT Number692113001
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/03/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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