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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 72404267
Medical Device Problem Code Material Puncture/Hole (1504)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/06/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device not returned for evaluation.
 
Event or Problem Description
It was reported that due to perforation in cylinder the patient had his inflatable penile prosthesis (ipp) removed and replaced.The ipp was explanted and a new device consisting of a 18 cm x 12 mm cylinders, pump and reservoir were implanted.It was further reported that there were no patient complications related to this event.
 
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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 Key8893413
Report Number2183959-2019-65675
Device Sequence Number18911635
Product Code FHW
UDI-Device Identifier00878953003757
UDI-Public00878953003757
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
N970012
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2018
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/14/2019
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 Date11/03/2010
Device Model Number72404267
Device Catalogue Number72404267
Device Lot Number570858003
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/25/2019
Initial Report FDA Received Date08/14/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age50 YR
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