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

Model Number 72404323

Device Problems Collapse (1099); Inflation Problem (1310); Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2020

Event Type  Injury  

Event 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 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.

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
• Type of Device: PROSTHESIS PENIS INFLATABLE| PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 10022443
• MDR Text Key: 189783642
• Report Number: 2183959-2020-02192
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953004075
• UDI-Public: 00878953004075
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 80