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

Model Number 72404238

Device Problems Collapse (1099); Inflation Problem (1310); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2020

Event Type  Injury  

Event Description

It was reported that the patient and physician were unable to activate an inflatable penile prosthesis (ipp).During imaging an air bubble appeared to be inside the pump.A surgical procedure was performed in which the existing device was removed.The patient did not experience any complication related to the device.A week later the patient underwent a reimplant procedure in which a new pump was implanted.

Manufacturer Narrative

Product investigation completed.The pump was visually inspected; no leaks were found.The pump was functionally tested and failed the 8lb.Activation test.The pump therefore required more than 8lbs.Of force to activate.Product analysis concluded that identified pump failed functional test was the most probable cause of the reported events.Based on the results of this investigation, no escalation is required.

Event Description

It was reported that the patient and physician were unable to activate an inflatable penile prosthesis (ipp).After numerous troubleshooting techniques the device would not inflate and the pump would dimple.During imaging an air bubble appeared to be inside the pump.A surgical procedure was performed in which the existing device was removed.The patient did not experience any complication related to the device.A week later the patient underwent a reimplant procedure in which a new pump was implanted.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 10697082
• MDR Text Key: 211881113
• Report Number: 2183959-2020-04819
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003511
• UDI-Public: 00878953003511
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/20/2021
• Device Model Number: 72404238
• Device Catalogue Number: 72404238
• Device Lot Number: 1000294245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES# 86562
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR