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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
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BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72404014
Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/10/2020
Event Type  Injury  
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.
 
Manufacturer Narrative
Additional information: b5.Device analysis: product analysis was unable to confirm the reported events through analysis of the cylinder and wqc.Functional, leak and visual inspection concluded the cylinder performed within specification.No abnormalities nor device malfunction were identified with the wqc.Based on this investigation, the investigation conclusion code of no problem detected was chosen because the reported events could not be confirmed nor substantiated through investigation of the cylinder and wqc.Based on the results of this investigation, no escalation is required.Pump 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.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.Analysis confirmed a pump malfunction as the most probable cause of the device malfunction.
 
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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 Key9689039
MDR Text Key180581247
Report Number2183959-2020-00569
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953002712
UDI-Public00878953002712
Combination Product (y/n)N
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 03/09/2020
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 Date04/01/2024
Device Model Number72404014
Device Catalogue Number72404014
Device Lot Number1000248042
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2020
Initial Date Manufacturer Received 01/13/2020
Initial Date FDA Received02/10/2020
Supplement Dates Manufacturer Received03/08/2020
Supplement Dates FDA Received03/09/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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