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

Model Number	72404321
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b additional pro code: fae the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the patient presented with an inflatable penile prosthesis (ipp) that was not positioned to reach the coronal grove of the penis.The patient experienced the tip of the penis drooping and collapsing when the device was fully inflated.The ipp rear tip extenders were replaced, and the physician suspected that the original implant was measured too short when implanted.There were no patient complications reported.
Additional Manufacturer Narrative
Updated h6 evaluation conclusion code.D2b additional pro code: fae.
Event or Problem Description
It was reported that the patient presented with an inflatable penile prosthesis (ipp) that was not positioned to reach the coronal grove of the penis.The patient experienced the tip of the penis drooping and collapsing when the device was fully inflated.The ipp rear tip extenders were replaced, and the physician suspected that the original implant was measured too short when implanted.There were no patient complications reported.

• Brand Name: RTE SNAPCONE
• Common Device Name: PROSTHESIS PENIS INFLATABLE| PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18749888
• Report Number: 2124215-2024-10309
• Device Sequence Number: 6271177
• Product Code: FHW
• UDI-Device Identifier: 00878953004051
• UDI-Public: 00878953004051
• 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: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2024

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 Model Number: 72404321
• Device Catalogue Number: 72404321
• Device Lot Number: 1100123887
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2024
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 70 KG