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

Model Number	72404011
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient went to the hospital due to the inflatable penile prosthesis (ipp) not working appropriately.Two weeks later, a replacement surgery was performed.It was noted that during the procedure, the existing pump and cylinders were removed and replaced; however, the previous reservoir was left in place and a new component was implanted.Upon explant, a tear was seen in the cylinder.The cause for the cylinder hole was not detailed by the facility.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this ams 700 underwent a thorough analysis.The cylinders were visually inspected identifying a hole consistent with sharp instrument damage in the proximal end of both rods.Both cylinders presented leaks in the proximal ends; however, this damage was consistent with sharp instrument damage likely occurring during explant.Visual inspection of the pump did not reveal any visual damager or abnormalities, and the pump passed the leak test.The pump was functionally tested not passing the activation tests 2 and 3.Based on the information available and analysis results, the reported allegation of a cylinder tear could not be confirmed; however, the pump not passing the activation tests could have caused or contributed to the reported clinical observation of the device not working appropriately.A conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the patient went to the hospital due to the inflatable penile prosthesis (ipp) not working appropriately.Two weeks later, a replacement surgery was performed.It was noted that during the procedure, the existing pump and cylinders were removed and replaced; however, the previous reservoir was left in place and a new component was implanted.Upon explant, a tear was seen in the cylinder.The cause for the cylinder hole was not detailed by the facility.There were 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: 17666848
• Report Number: 2124215-2023-46750
• Device Sequence Number: 12319303
• Product Code: FHW
• UDI-Device Identifier: 00878953002682
• UDI-Public: 00878953002682
• 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: 2016
• 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): 10/12/2023

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: 04/13/2021
• Device Model Number: 72404011
• Device Catalogue Number: 72404011
• Device Lot Number: 129977003
• 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: 08/17/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2016
• 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: 72404310/133371003; PUMP: 72404310/133371003; RESERVOIR: 720182-01/124844017; RESERVOIR: 720182-01/124844017
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male