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

Model Number 72404013

Device Problems Mechanical Problem (1384); Material Puncture/Hole (1504)

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

Event Date 12/22/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent a surgical procedure to revise this inflatable penile prosthesis (ipp) due to the device not working properly that started two weeks prior to the procedure.The ipp cylinder and pump were explanted and replaced with a new ipp cylinder and pump.During the revision procedure the physician found that one of the cylinders contained a hole, the hole origination is unknown.It was found that the cylinder did not expand due to saline leakage due to the cylinder hole.The patient was stable following the procedure.

Manufacturer Narrative

The ams700 ipp cylinder was visually inspected and functionally tested.Cylinder has a leak in the distal cylinder body that was the result of sharp instrument damage consistent with explant damage; hole was present.Due to this damage being consistent with explant it will be considered a secondary failure.Cylinder has fold that indicate possible buckling of the cylinders in the proximal cylinder body.Cylinder was not pressure test due to leak was identified.The ams 700 momentary squeeze (ms) pump was visually inspected; no leaks were found.The tubing was identified to be cut down to the pump block.The tubing was not returned for analysis.The pump was functionally tested and failed the 8lb.Activation test.The pump therefore required more than 8lbs.Of force to activate.Product analysis was unable to confirm the reported event.

Event Description

It was reported that the patient underwent a surgical procedure to revise this inflatable penile prosthesis (ipp) due to the device not working properly that started two weeks prior to the procedure.The ipp cylinder and pump were explanted and replaced with a new ipp cylinder and pump.During the revision procedure the physician found that one of the cylinders contained a hole, the hole origination is unknown.It was found that the cylinder did not expand due to saline leakage due to the cylinder hole.The patient was stable following the procedure.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 11154485
• MDR Text Key: 226251507
• Report Number: 2183959-2020-06363
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953002705
• UDI-Public: 00878953002705
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 72404013
• Device Catalogue Number: 72404013
• Device Lot Number: 1000320477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Date Manufacturer Received: 01/28/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR