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

Model Number	72404323
Medical Device Problem Codes	Collapse (1099); Inflation Problem (1310); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had the inflatable penile prosthesis removed due to malfunction as the device failed to erect properly.No air or holes were observed, but the pump bulb stayed flat.A new inflatable penile prosthesis was implanted, there were no patient complications reported.The patient was stable and the event resolved.
Event or Problem Description
It was reported that the patient had the inflatable penile prosthesis removed due to malfunction as the device failed to erect properly.No air or holes were observed, but the pump bulb stayed flat.A new inflatable penile prosthesis was implanted, there were no patient complications reported.The patient was stable and the event resolved.
Additional Manufacturer Narrative
D10, h3, h6, h10.H3 device evaluation: two rear tip extenders (rtes) were received and visually inspected.No damage nor abnormalities were identified.No other components were received.Product analysis was unable to confirm the reported events.

• 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: 10022443
• Report Number: 2183959-2020-02192
• Device Sequence Number: 2502530
• Product Code: FHW
• UDI-Device Identifier: 00878953004075
• UDI-Public: 00878953004075
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2020

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 Date: 03/11/2022
• Device Model Number: 72404323
• Device Catalogue Number: 72404323
• Device Lot Number: 0168215066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Initial Date Received by Manufacturer: 04/21/2020
• Supplement Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 05/04/2020
• Supplement Report FDA Received Date: 07/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 80