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

Model Number	72404281
Medical Device Problem Codes	Collapse (1099); Deflation Problem (1149); Inflation Problem (1310); Mechanical Problem (1384); Material Deformation (2976)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	08/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that at the time of activation of this inflatable penile prosthesis, the physician was unable to activate the prosthesis and was unable to inflate or deflate the device.The physician noted that the pump remained collapsed, the deflation button was pressed, however there was no saline solution flow from the cylinders to the reservoir.A deflation maneuver was attempted several times without achieving results.The patient presented a lot of discomfort on palpation, so it was proposed to perform troubleshooting under sedation so as not to cause him more discomfort.During the review under sedation and after several maneuvers it is determined that the pump was not working correctly.The device would partially inflate but it was not possible to deflate.The patient was expected to undergo a revision surgery, however, no further details were available.No patient complications were reported.
Event or Problem Description
It was reported that, at the time of activation of this inflatable penile prosthesis, the physician was unable to activate the prosthesis and was unable to inflate or deflate the device.The pump remained collapsed, the deflation button was pressed, however there was no saline solution flow from the cylinders to the reservoir.A deflation maneuver was attempted several times without success.The patient presented with a lot of discomfort on palpation, so troubleshooting under sedation was proposed so as not to cause him more discomfort.During examination under sedation and after performing several troubleshooting maneuvers, it was determined that the pump was not working correctly.The device would partially inflate but would not deflate.An obstruction between the pump and reservoir that prevented the prosthesis from filling and deflating.A replacement surgery was performed, during which it was observed that the tube from the pump to the reservoir was twisted in several turns.This obstruction was due to an abnormal twist in the tube detected until the replacement surgery.The tubes from the pump to the cylinders were intact.No further patient complications were reported.
Additional Manufacturer Narrative
Upon receipt of this inflatable penile prosthesis (ipp) images at our quality assurance laboratory, the images were reviewed.The images showed the pump tubing leading to the reservoir component was twisted/kinked to the extent where fluid flow would be obstructed.A lack of fluid flowing from the reservoir component to the pump and cylinders could result in the reported clinical allegations of pump mechanical issue, pump collapse, device inflation issue, and device deflation issue.The allegation of discomfort is a known inherent risk associated with implantation and use of an ipp device documented in the product labeling.Based on the information available and review of the media, the reported issues were unable to be confirmed as the device was not returned; therefore, the conclusion code of cause not established has been chosen.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.Both cylinders were microscopically inspected and tested for leaks, and both of them passed all testing.The pump was microscopically inspected, and leak and functionality tested.No damage or abnormalities were noted, no leaks were identified in the pump.The reservoir was microscopically inspected and tested for leaks.Microscope examination revealed that the reservoir kink resistant tubing (krt) was worn to the filament, and its tubing was kinked.No leaks were identified in the reservoir.Based on the information available and analysis results, the kinked tubing identified in the reservoir could have caused or contributed to the reported clinical observation of tube twisted.
Event or Problem Description
It was reported that, at the time of activation of this inflatable penile prosthesis, the physician was unable to activate the prosthesis and was unable to inflate or deflate the device.It was confirmed that at the initial implant of this device, the device was inflated post op and deflated one day later.The pump remained collapsed, the deflation button was pressed, however there was no saline solution flow from the cylinders to the reservoir.A deflation maneuver was attempted several times without success.The patient presented with a lot of discomfort on palpation, so troubleshooting under sedation was proposed so as not to cause him more discomfort.During examination under sedation and after performing several troubleshooting maneuvers, it was determined that the pump was not working correctly.The device would partially inflate but would not deflate.An obstruction between the pump and reservoir that prevented the prosthesis from filling and deflating.A replacement surgery was performed, during which it was observed that the tube from the pump to the reservoir was twisted in several turns.This obstruction was due to an abnormal twist in the tube detected until the replacement surgery.The tubes from the pump to the cylinders were intact.No further patient complications were reported.

• 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: 17737163
• Report Number: 2124215-2023-49963
• Device Sequence Number: 5648791
• Product Code: FHW
• UDI-Device Identifier: 00878953003849
• UDI-Public: 00878953003849
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2024

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: 03/03/2026
• Device Model Number: 72404281
• Device Catalogue Number: 72404281
• Device Lot Number: 1000533046
• 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: 08/29/2023
• Supplement Date Received by Manufacturer: 02/27/2024; 04/17/2024
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 03/22/2024; 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR UPN 720182-01 LOT 1000590569; RESERVOIR UPN 720182-01 LOT 1000590569
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male