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

Model Number 72404310

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2020

Event Type  Injury  

Manufacturer Narrative

Device analysis: product analysis concluded a pump malfunction based on the identification of a pump functional test failure.The pump failed the inflation test and did not transfer a sufficient amount of fluid to fully inflate the cylinders.Although an allegation related to a "fluid leak" with the cylinders was reported, based on the cylinders performing within specification, the pump was concluded as the most probable cause of the reported events.An inflation issue with the pump would result in the cylinders not sufficiently inflating and could present as a fluid leak to the user.The cylinder investigation did not identify any abnormalities nor device malfunctions; the cylinders performed within specification.The identified pump malfunction is therefore concluded as the most probable cause of the reported events as an inflation issue would result in the device operating different than normal and could present as a leak as the cylinders would not fully inflate with this malfunction.The product record review indicated that the reported events do not represent an unanticipated event.Review of the manufacturing documentation confirmed all required in-process and final inspections and testing were completed.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 through product investigation.Based on the results of this investigation, no escalation is required.

Event Description

It was reported that the patient underwent a revision procedure due to connector disorder with an inflatable penile prosthesis (ipp).The ipp left cylinder and pump was explanted and a new ipp cylinder and pump was implanted.Additional information was reported that the connection at the cylinder side of the tube was the connection issue, the patient presented with the device not working two weeks prior to the revision procedure and got well 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4089353452
• MDR Report Key: 9868463
• MDR Text Key: 185927357
• Report Number: 2183959-2020-01488
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003986
• UDI-Public: 00878953003986
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2020

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: 12/19/2023
• Device Model Number: 72404310
• Device Catalogue Number: 72404310
• Device Lot Number: 1000206074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 03/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention