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

Model Number 72404232-10

Device Problem Difficult or Delayed Activation (2577)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/30/2020

Event Type  Injury  

Event Description

It was reported that the patient will have a revision of an inflatable penile prosthesis(ipp) pump due to the pump not working at activation.No patient complications were reported.

Event Description

It was reported that the patient had a revision of an inflatable penile prosthesis(ipp) pump due to the pump not working at activation.No patient complications were reported.

Manufacturer Narrative

Investigation summary: an allegation related to pump failed to activate was reported.Product analysis concluded these activation issues could affect the functionality of the pump.Device technical analysis: the ams 700 momentary squeeze (ms) pump was visually inspected and functionally tested; 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 these activation issues could affect the functionality of the pump.Product analysis confirmed pump malfunction.Device history record (dhr): review of manufacturing documentation was performed to ensure that all required in-process and final inspections and testing were completed.Review of the manufacturing records for batch 1000300231 found no evidence that the device failed to meet applicable product specifications prior to shipment from boston scientific.Labeling review: there is no objective evidence that the user did not properly handle or use the device according to the ifu, ams700 ms pump.Additionally, the reported events do not contain an allegation against the labeling.Conclusion: based on this investigation, the investigation conclusion code of cause traced to component failure was chosen because the reported events could be traced to a component failure.

• 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: 11168670
• MDR Text Key: 226770475
• Report Number: 2183959-2021-00046
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953009780
• UDI-Public: 00878953009780
• 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
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/08/2021
• Device Model Number: 72404232-10
• Device Catalogue Number: 72404232-10
• Device Lot Number: 1000300231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Manufacturer Received: 12/30/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 02/16/2021
• Supplement Dates FDA Received: 03/09/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR