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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
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BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72404252-10
Device Problems Defective Device (2588); Malposition of Device (2616)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/02/2019
Event Type  malfunction  
Event Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) original implant.For the procedure an lgx ipp was opened and prepped but upon implant, the surgeon noted the cylinders and pump were manufactured "backwards" as the deflate button faced anterior to the patient.The physician indicated that this has been a recurring issue and has occurred multiple times.A new lgx ipp was implanted to finish the procedure.The patient did not experience any further complications.
 
Event Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) original implant.For the procedure an lgx ipp was opened and prepped but upon implant, the surgeon noted the cylinders and pump were manufactured "backwards" as the deflate button faced anterior to the patient.The physician indicated that this has been a recurring issue and has occurred multiple times.A new lgx ipp was implanted to finish the procedure.The patient did not experience any further complications.Additional information was received in which it was stated that the physician suspected the device was placed incorrectly in the packaging causing the device to "set" in a specific orientation.When the device was attempted to be switched into another orientation it was unable to be completed and would revert back into the original orientation.No more information available at the moment.Should additional information become available, it will be provided.
 
Manufacturer Narrative
Ncep-00114946 was opened to further investigate and document the investigation for the ams 700 packaging requirements.Product investigation completed.Product analysis did not confirm the reported events.Visual and functional testing of the cylinders and pump concluded the components performed within specification.As confirmed by the manufacturing and operations quality engineer, the inflatable penile prosthesis (ipp) does not have a specified orientation, resulting in the device unable to be manufactured backwards.The allegation could not be confirmed nor replicated.Based on the results of this investigation, no escalation is required.
 
Event Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) original implant.For the procedure an lgx ipp was opened and prepped but upon implant, the surgeon noted the cylinders and pump were manufactured "backwards" as the deflate button faced anterior to the patient.The physician indicated that this has been a recurring issue and has occurred multiple times.A new lgx ipp was implanted to finish the procedure.The patient did not experience any further complications.
 
Manufacturer Narrative
Product investigation completed.Product analysis did not confirm the reported events.Visual and functional testing of the cylinders and pump concluded the components performed within specification.As confirmed by the manufacturing and operations quality engineer, the inflatable penile prosthesis (ipp) does not have a specified orientation, resulting in the device unable to be manufactured backwards.The allegation could not be confirmed nor replicated.Based on the results of this investigation, no escalation is required.
 
Manufacturer Narrative
B5, d6, d7, h2, h6, h10 updated.H2, h3, h6, h10 updated.Product investigation completed.Product analysis did not confirm the reported events.Visual and functional testing of the cylinders and pump concluded the components performed within specification.As confirmed by the manufacturing and operations quality engineer, the inflatable penile prosthesis (ipp) does not have a specified orientation, resulting in the device unable to be manufactured backwards.The allegation could not be confirmed nor replicated.Based on the results of this investigation, no escalation is required.
 
Event Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) original implant.For the procedure an lgx ipp was opened and prepped but upon implant, the surgeon noted the cylinders and pump were manufactured "backwards" as the deflate button faced anterior to the patient.The physician indicated that this has been a recurring issue and has occurred multiple times.A new lgx ipp was implanted to finish the procedure.The patient did not experience any further complications.Additional information was received in which it was stated that the physician suspected the device was placed incorrectly in the packaging causing the device to "set" in a specific orientation.When the device was attempted to be switched into another orientation it was unable to be completed and would revert back into the original orientation.No more information available at the moment.Should additional information become available, it will be provided.
 
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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 Key9521871
MDR Text Key175446328
Report Number2183959-2019-68329
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953009810
UDI-Public00878953009810
Combination Product (y/n)N
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup,Followup
Report Date 03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/18/2021
Device Model Number72404252-10
Device Catalogue Number72404252-10
Device Lot Number1000292778
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2019
Date Manufacturer Received02/25/2020
Patient Sequence Number1
Patient Age63 YR
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