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

Model Number	720182-01
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Serious Injury
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.B3 event date: estimated as two weeks prior to explant.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) presented to the hospital because the device was not functioning properly.Two weeks later, the patient underwent surgical intervention to revise the ipp and a crack in the reservoir connecting tube was found.The device was explanted and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this inflatable penile prosthesis was thoroughly inspected and analyzed.Visual inspection of the cylinders found no evidence of damage or abnormality.The cylinders passed microscopic and leak testing.The reservoir exhibited signs of damage consistent with explant but passed leak testing.The pump component passed microscopic and leak testing, but did not pass inflation and deflation testing.Based on the results of the product analysis, the reported observations of non-functioning device and hole in tubing were confirmed and most likely cause traced to component failure.B3 event date: estimated as two weeks prior to explant.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) presented to the hospital because the device was not functioning properly.Two weeks later, the patient underwent surgical intervention to revise the ipp and a crack in the reservoir connecting tube was found.The device was explanted and replaced.There were no patient complications reported.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) presented to the hospital because the device was not functioning properly.Two weeks later, the patient underwent surgical intervention to revise the ipp and a crack in the reservoir connecting tube was found.The device was explanted and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Additional information provided on the device analysis required update to the product investigation: upon receipt at our post market quality assurance laboratory, this inflatable penile prosthesis was thoroughly inspected and analyzed.Visual inspection of the cylinders found no evidence of damage or abnormality.The cylinders passed microscopic and leak testing.The reservoir exhibited signs of damage consistent with explant but passed leak testing.The pump component passed microscopic and leak testing, but did not pass the activation testing performed.Based on the results of the product analysis, the reported observations of non-functioning device and hole in tubing were confirmed and most likely cause traced to component failure.B3 event date: estimated as two weeks prior to explant.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18560194
• Report Number: 2124215-2024-03001
• Device Sequence Number: 20862305
• Product Code: FHW
• UDI-Device Identifier: 00878953005676
• UDI-Public: 00878953005676
• 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: 2023
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 05/10/2024

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: 04/16/2024
• Device Model Number: 720182-01
• Device Catalogue Number: 720182-01
• Device Lot Number: 1000262497
• 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: 01/04/2024
• Supplement Date Received by Manufacturer: 04/12/2024; 04/19/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 04/16/2024; 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2019
• 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: CYLINDER 14 CM: UPN: 72404012 LOT#: 1100078940; CYLINDER 14 CM: UPN: 72404012 LOT#: 1100078940; CYLINDER 16 CM: UPN: 72404013 LOT#: 1100096824; CYLINDER 16 CM: UPN: 72404013 LOT#: 1100096824; CYLINDER: 72404012 _1100078940; CYLINDER: 72404013_1100096824; PUMP: 72404310_ 1100160792; PUMP: UPN:72404310 LOT#: 1100160792; PUMP: UPN:72404310 LOT#: 1100160792
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male