MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RTE SNAPCONE; PROSTHESIS PENIS INFLATABLE| PROSTHESIS PENILE

Model Number	72404323
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a replacement surgery due to an unspecified reason.The previous 3.0 cm rte was removed, and replaced with 5.0cm rte.Further information was requested and not yet received.Should additional relevant details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient underwent a replacement surgery due to an unspecified reason.The previous 3.0 cm rte was removed, and replaced with 5.0cm rte.Further information was requested and not yet received.Should additional relevant details become available, a supplemental report will be submitted.Additional information was received indicating the 3.0 cm rte was replaced with the 5.0 cm rte because the implant appeared too short.No patient complications were reported during the procedure.
Additional Manufacturer Narrative
Event updated with additional information.Device code updated to code 2588.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/17/2018 01:13 pm ct.The report number is being corrected from: 2183959-2018-61739 to: 2183959-2018-61038.

• 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 Key: 8089878
• Report Number: 2183959-2018-61038
• Device Sequence Number: 13890097
• Product Code: FHW
• UDI-Device Identifier: 00878953004075
• UDI-Public: 00878953004075
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2019

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 Date: 05/01/2023
• Device Model Number: 72404323
• Device Catalogue Number: 72404323
• Device Lot Number: 1000100428
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 01/22/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 54 YR