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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 72404310
Device Problems Inflation Problem (1310); Loose or Intermittent Connection (1371)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/03/2019
Event Type  Injury  
Event Description
It was reported that the patient underwent a revision procedure due to left cylinder connector disorder with an inflatable penile prosthesis (ipp).The ipp pump was explanted and a new ipp pump was implanted.Additional information was reported that the patient presented with inflation issues two weeks prior to revision procedure at the junction of the left cylinder.The patient recovered post surgery.
 
Manufacturer Narrative
Product analysis: product analysis could not confirm the reported events as pump contamination was present resulting in an inability to functionally test the pump.No connectors returned; the allegation of "connector disorder" could not be confirmed.Based on this investigation, the investigation conclusion code of cause not established was chosen because the reported events could not be confirmed or substantiated through investigation of the pump component and the connectors did not return.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 left cylinder connector disorder with an inflatable penile prosthesis (ipp).The ipp pump was explanted and a new ipp pump was implanted.Additional information was reported that the patient presented with inflation issues two weeks prior to revision procedure at the junction of the left cylinder.The patient recovered post surgery.
 
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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 Key9484138
MDR Text Key176007488
Report Number2183959-2019-68202
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953003801
UDI-Public00878953003801
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 02/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date05/30/2022
Device Model Number72404310
Device Catalogue Number72404310
Device Lot Number0176308007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2020
Date Manufacturer Received01/31/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age63 YR
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