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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 Problems Collapse (1099); Failure to Cycle (1142); Inflation Problem (1310)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/15/2020
Event Type  Injury  
Event Description

It was reported that the patient underwent an inflatable penile prosthesis (ipp) procedure due to the patient experienced inflation issues. Patient requested that pump be replaced. Attempts to operate the pump prior to incision were done but it did not improve. Fluid would move into the cylinders from the pump, but fluid would not return to the pump from the reservoir. The pump valve stayed flat. The pump was replaced. New pump worked great intra op and immediately post-op. No further patient complications were reported.

 
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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
4089353452
MDR Report Key10118776
MDR Text Key193980772
Report Number2183959-2020-02423
Device Sequence Number1
Product Code FHW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberN970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/02/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/04/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/15/2021
Device MODEL Number72404232-10
Device Catalogue Number72404232-10
Device LOT Number1000215592
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/01/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/16/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/04/2020 Patient Sequence Number: 1
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