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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RTE SNAPCONE; PROSTHESIS PENIS INFLATABLE| PROSTHESIS PENILE
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BOSTON SCIENTIFIC CORPORATION RTE SNAPCONE; PROSTHESIS PENIS INFLATABLE| PROSTHESIS PENILE Back to Search Results
Model Number 72404322
Medical Device Problem Code Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code Pain (1994)
Date of Event 12/07/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure due to rear tip extenders (rte's) being oversized with an inflatable penile prosthesis (ipp).The ipp remains implanted and active and only the rte's were explanted.Additional information was reported that the patient presented to the physician buckling when inflated and pain and the patient is positive following the procedure.
 
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Brand Name
RTE SNAPCONE
Common Device Name
PROSTHESIS PENIS INFLATABLE| PROSTHESIS PENILE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key9592787
Report Number2183959-2020-00094
Device Sequence Number3244564
Product Code FHW
UDI-Device Identifier00878953004068
UDI-Public00878953004068
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
N970012
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/15/2020
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 Date06/04/2024
Device Model Number72404322
Device Catalogue Number72404322
Device Lot Number1000286328
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/17/2019
Initial Report FDA Received Date01/15/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age53 YR
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