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

Model Number	72404322
Medical Device Problem Codes	Disconnection (1171); Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Premarket / 510(k) #: n970012, k090663.Product investigation completed.As the complaint component was not returned for analysis, no product analysis could be performed.The reported allegations could not be confirmed.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.
Event or Problem Description
It was reported that after the first attempt to introduce the right inflatable penile prosthesis (ipp) cylinder the 2 cm rear tip extender (rte) got stuck due a tight corpus cavernosum, detached itself from the cylinder and migrated towards the crura of the penis.This complicated the procedure as it took an hour and a half more.After several attempts, the physician was able to remove the rte and replace it with a 1.5 cm rte.The procedure was completed successfully with no further patient complications.

• 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: 11340475
• Report Number: 2183959-2021-00495
• Device Sequence Number: 10968669
• Product Code: FHW
• UDI-Device Identifier: 00878953004068
• UDI-Public: 00878953004068
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2021

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: Health Professional
• Device Expiration Date: 09/17/2024
• Device Model Number: 72404322
• Device Catalogue Number: 72404322
• Device Lot Number: 1000334012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/17/2021
• 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: 61 YR