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

Model Number	72404272
Medical Device Problem Codes	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	05/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient went to the hospital because this inflatable penile prosthesis (ipp) was not working properly.A surgical procedure was performed during which a tear in the cylinder was noted.The cylinders and the pump were removed and replaced with no patient complications.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.Both cylinders were visually and leak tested.Visual inspection revealed that both cylinders had wear at a fold in its bodies.In addition, it was noted that there were holes in the distal end of the cylinders as a result of a sharp instrument, most likely occurred during the explant procedure, therefore, cylinder 1 and cylinder 2 did not pass the leak test.The pump was visually inspected, and leakage tested.During visual examination, it was identified that the kink resistant tubing (krt) had worn down to the filament, the pump block had scaling, and the bulb had worn down from krt wear.No leaks were identified in the pump.Based on the information available and analysis results, the reported clinical observation of a tear in the cylinder 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 the patient went to the hospital because this inflatable penile prosthesis (ipp) was not working properly.A surgical procedure was performed during which a tear in the cylinder was noted.The cylinders and the pump were removed and replaced with no patient complications.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17003611
• Report Number: 2124215-2023-26211
• Device Sequence Number: 17986597
• Product Code: FHW
• UDI-Device Identifier: 00878953003795
• UDI-Public: 00878953003795
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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
• Report Date (Section B): 08/10/2023

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: 12/20/2017
• Device Model Number: 72404272
• Device Catalogue Number: 72404272
• Device Lot Number: 806370005
• 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: 05/08/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2012
• 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: PUMP: UPN: 72401110 / LOT: 796976002; PUMP: UPN: 72401110 / LOT: 796976002; RESERVOIR: UPN: 72400152 / LOT: 803526009; RESERVOIR: UPN: 72400152 / LOT: 803526009
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male