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

Model Number	72404320
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Unspecified Tissue Injury (4559)
Date of Event	08/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during this inflatable penile prosthesis (ipp) original procedure, a distal crossover of the cylinders occurred while implanting the components.In addition, when placing the right cylinder, its rear tip extender (rte) detached.The medical staff attempted to retrieve it but was unable to locate it within the corpora; therefore, a cystoscopy was performed, during which the rte was visualized.However, despite multiple attempts over several minutes to retrieve it, the efforts were unsuccessful, so it was decided to implant the cylinder and complete the procedure.There were no further patient complications reported.
Additional Manufacturer Narrative
Additional information updated: h6: evaluation conclusion codes.
Event or Problem Description
It was reported that, during this inflatable penile prosthesis (ipp) original procedure, a distal crossover of the cylinders occurred while implanting the components.In addition, when placing the right cylinder, its rear tip extender (rte) detached.The medical staff attempted to retrieve it but was unable to locate it within the corpora; therefore, a cystoscopy was performed, during which the rte was visualized.However, despite multiple attempts over several minutes to retrieve it, the efforts were unsuccessful, so it was decided to implant the cylinder and complete the procedure.There were no further 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: 20247346
• Report Number: 2124215-2024-57965
• Device Sequence Number: 7301210
• Product Code: FHW
• UDI-Device Identifier: 00878953004044
• UDI-Public: 00878953004044
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72404320
• Device Catalogue Number: 72404320
• Device Lot Number: 1100449501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 10/21/2024
• Date Device Manufactured: 02/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CYLINDERS/PUMP: UPN: 72404234-14 / LOT: 1100419901.; CYLINDERS/PUMP: UPN: 72404234-14 / LOT: 1100419901.; RESERVOIR: UPN: 720185-01 / LOT: 1100548694.; RESERVOIR: UPN: 720185-01 / LOT: 1100548694.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Male