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

Model Number	72404323
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: product code: fhw|fae.H4: premarket / 510(k) #: n970012|k090663.
Event or Problem Description
It was reported that, during the preparation for a penile prosthesis procedure, a foreign material inside the sterile packaging of the rear tip extenders (rtes) was detected; therefore, those rtes were not utilized.Other rtes were used to successfully complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
D2b: product code: fhw|fae.H4: premarket / 510(k) #: n970012|k090663.Upon receipt at our quality assurance laboratory, the returned component underwent a thorough analysis.The rear tip extenders (rte) was visually and microscopically inspected.No damage or abnormalities were noted in the rte.Based on the information available and analysis results, the reported clinical observation of a foreign material inside the sterile packaging of the rear tip extenders (rte) could not be confirmed; therefore, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that, during the preparation for a penile prosthesis procedure, a foreign material inside the sterile packaging of the rear tip extenders (rtes) was detected; therefore, those rtes were not utilized.Other rtes were used to successfully complete the procedure.There were no patient complications.

• 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17302191
• Report Number: 2124215-2023-36409
• Device Sequence Number: 3864269
• Product Code: FHW
• UDI-Device Identifier: 00878953004075
• UDI-Public: 00878953004075
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72404323
• Device Catalogue Number: 72404323
• Device Lot Number: 1100294758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• 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
• Patient Sex: Unknown