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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 72404323
Medical Device Problem Code Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/08/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient had his inflatable penile prosthesis rear tip extenders (rte) removed due to a potential crossover leading to a decrease in potential girth.During the revision surgery the physician felt there was no crossover and downsized the rte to a total length of 2.5 cm rather than the previous 3.0 cm indicating a slight buckle with the old 3.0 rte.The new rte were put in and desired result was achieved.
 
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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 Key8307488
Report Number2183959-2019-60608
Device Sequence Number1063914
Product Code FHW
UDI-Device Identifier00878953004075
UDI-Public00878953004075
Combination Product (Y/N)N
Initial Reporter StateNV
Initial Reporter CountryUS
PMA/510(K) Number
N970012
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/05/2019
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 Date02/11/2023
Device Model Number72404323
Device Catalogue Number72404323
Device Lot Number1000055177
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/08/2019
Initial Report FDA Received Date02/05/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age46 YR
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