MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC

Model Number	72404268
Medical Device Problem Codes	Inflation Problem (1310); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient visited the hospital because his inflatable penile prosthesis (ipp) is not inflating.A cylinder is perforated.The patient was scheduled for surgery.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
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 visited the hospital because his inflatable penile prosthesis was not inflating, a cylinder was perforated.The patient underwent surgery a month later, all components were removed and replaced.The specific device problem could not be identified.There were no reported patient complications.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis underwent a thorough analysis.The cylinders were visually and microscopically examined, and leak tested.Both cylinders exhibited holes in the proximal end of the cylinders from a sharp instrument damage and tool marks, which probably occurred during the explant procedure.The pump was microscopically examined and functionally tested.The pump kink resistant tubing (krt) was worn down to the filament.In addition, the pump did not pass the deflation and activation tests.Based on the information available and analysis results, the deflation and activation issues identified in the pump confirmed the reported device inflation anomaly.Based on the information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the patient visited the hospital because his inflatable penile prosthesis was not inflating, a cylinder was perforated.The patient underwent surgery a month later, all components were removed and replaced.The specific device problem could not be identified.There were no reported patient complications.
Event or Problem Description
It was reported, that the patient visited the hospital, because his inflatable penile prosthesis was not inflating, a cylinder was perforated.The patient underwent surgery a month later, all components were removed and replaced.The specific device problem could not be identified.There were no reported patient complications.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis underwent a thorough analysis.The cylinders were visually and microscopically examined and leak tested.Both cylinders exhibited holes in the proximal end of the cylinders from a sharp instrument damage and tool marks.Which probably occurred, during the explant procedure.The pump was microscopically examined and functionally tested.The pump kink resistant tubing (krt) was worn down to the filament.In addition, the pump did not pass activation testing.Based on the information available and analysis results, the activation issues identified in the pump confirmed, the reported device inflation anomaly.Based on the information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• 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: 17798321
• Report Number: 2124215-2023-51463
• Device Sequence Number: 18014864
• Product Code: FHW
• UDI-Device Identifier: 00878953003764
• UDI-Public: 00878953003764
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• 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,Followup,Followup
• Report Date (Section B): 05/06/2024

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: Lay User/Patient
• Device Expiration Date: 03/27/2019
• Device Model Number: 72404268
• Device Catalogue Number: 72404268
• Device Lot Number: 0169050009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 10/11/2023; 03/20/2024; 05/01/2024
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 10/30/2023; 04/03/2024; 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2017
• 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: RESERVOIRUPN: 72404155LOT: 0169005017; RESERVOIRUPN: 72404155LOT: 0169005017; RESERVOIRUPN: 72404155LOT: 0169005017; RESERVOIRUPN: 72404155LOT: 0169005017
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male