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

Model Number	72404323
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	03/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) revision surgery in which the right rear tip extender, which was too long, was removed and replaced with a shorter one.No further information was provided.No patient complications were reported.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Neither the reported patient symptoms or device performance allegation can be confirmed.Based on the information available, a conclusion code of no problem detected was assigned to this investigation.The implant date and lot number were unable to be obtained through good faith efforts.The data was obtained through a review of the surgical history previously provided by the physician.
Additional Manufacturer Narrative
The complaint component has not been returned; therefore, no physical or visual analysis of the product could be performed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Due to the lack of product return, the clinical observations of rear tip extender rte too long could not be confirmed.The implant date and lot number were unable to be obtained through good faith efforts.The data was obtained through a review of the surgical history previously provided by the physician.
Event or Problem Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) revision surgery in which the right rear tip extender, which was too long, was removed and replaced with a shorter one.No further information was provided.No patient complications were 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 14160956
• Report Number: 2124215-2022-12130
• Device Sequence Number: 12201223
• Product Code: FHW
• UDI-Device Identifier: 00878953004075
• UDI-Public: 00878953004075
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2022

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: 03/08/2018
• Device Model Number: 72404323
• Device Catalogue Number: 72404323
• Device Lot Number: 820804017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2013
• 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: 74 YR
• Patient Sex: Male