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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 72404257
Device Problem Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/20/2024
Event Type  Injury  
Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported issue is a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
 
Event Description
It was reported that the cylinder of this inflatable penile prosthesis was herniated.The cylinder migrated from corporal body.The anatomy location of cylinder after migration is unknown.All the components were explanted and replaced.There were no patient complications 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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer Contact
farshad fahimi
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key19075460
MDR Text Key339772776
Report Number2124215-2024-21591
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953003658
UDI-Public00878953003658
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/09/2024
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 Model Number72404257
Device Catalogue Number72404257
Device Lot Number1100340258
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/20/2024
Initial Date FDA Received04/09/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/07/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
REAR TIP EXTENDER: 72404322/1100289651; RESERVOIR: 720185-01/1100347241
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age59 YR
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