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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 72404234
Medical Device Problem Codes Degraded (1153); Mechanical Problem (1384)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/01/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Medical device: 720185-01, 893501002, reservoir flat iz 100 ml.
 
Event or Problem Description
It was reported that patient contacted the physician complaining of a malfunctioning inflatable penile prosthesis (ipp) device (reportedly noticed about 3 months ago around (b)(6) 2019).Upon examination and mri it was observed that one cylinder had aneurysm.Physician explanted the cylinders and pump but had to leave the reservoir in place.He also visually confirmed the aneurysm in the affected cylinder patient was grafted and reimplanted with a coloplast titan.
 
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Brand Name
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
Common Device Name
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key9382712
Report Number2183959-2019-67708
Device Sequence Number469569
Product Code FHW
UDI-Device Identifier00878953003474
UDI-Public00878953003474
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
N970012
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/27/2019
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
Operator of Device Lay User/Patient
Device Expiration Date06/11/2016
Device Model Number72404234
Device Catalogue Number72404234
Device Lot Number886717002
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/06/2019
Initial Report FDA Received Date11/27/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age64 YR
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