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

Model Number	72404324
Medical Device Problem Codes	Mechanical Problem (1384); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The implant date, lot number, manufacture date and expiration date were unable to be obtained though good faith efforts.The data was obtained through a review of the surgical history previously provided by the physician.Other product code: (b)(4).
Event or Problem Description
It was reported that the patient experienced buckling with an inflatable penile prosthesis (ipp) due to incorrect rear tip extender (rte) sizing as they were too long.A surgical procedure was performed in which the rtes were removed and replaced for shorter ones.The original device was used to complete the procedure.There were no patient complications related to the event.

• 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: 11599466
• Report Number: 2183959-2021-01237
• Device Sequence Number: 14326447
• Product Code: FHW
• UDI-Device Identifier: 00878953004082
• UDI-Public: 00878953004082
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/19/2024
• Device Model Number: 72404324
• Device Catalogue Number: 72404324
• Device Lot Number: 1000361212
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 03/31/2021
• 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: 55 YR