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

Model Number	72404282-10
Medical Device Problem Codes	Deflation Problem (1149); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon preparing the device, the scrub tech having difficulty deflating the device.Proper steps were taken when preparing the device and the device inflated, but when pressing the release valve, no fluid would exit the cylinders.The physician tried several trouble shooting techniques such as the hard reset and alternating between the inflate bulb and deflate button.At one point, we were able to deflate the device, but upon re-inflating, the same issue occurred.The physician was not comfortable implanting this device, so an alternate device was used to complete the procedure.A valve issue within the pump was suspected.There were no patient complications related to this event.
Event or Problem Description
It was reported that upon preparing the device, the scrub tech having difficulty deflating the device.Proper steps were taken when preparing the device and the device inflated, but when pressing the release valve, no fluid would exit the cylinders.The physician tried several trouble shooting techniques such as the hard reset and alternating between the inflate bulb and deflate button.At one point, we were able to deflate the device, but upon re-inflating, the same issue occurred.The physician was not comfortable implanting this device, so an alternate device was used to complete the procedure.A valve issue within the pump was suspected.There were no patient complications related to this event.
Additional Manufacturer Narrative
Upon receipt of the inflatable penile prosthesis (ipp) at our quality assurance laboratory the returned components underwent a thorough analysis.Inspection of the cylinders and pump found no abnormalities and passed the leak testing.The pump also passed the functional testing performed.Based on the information available, the reported observations were unable to be confirmed.

• 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: 19233907
• Report Number: 2124215-2024-26693
• Device Sequence Number: 17559208
• Product Code: FHW
• UDI-Device Identifier: 00878953009834
• UDI-Public: 00878953009834
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2026
• Device Model Number: 72404282-10
• Device Catalogue Number: 72404282-10
• Device Lot Number: 1000551576
• 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: 04/12/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2021
• 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
• Patient Age: 77 YR
• Patient Sex: Male