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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 72404232-10
Device Problems Inflation Problem (1310); Device Contamination with Chemical or Other Material (2944)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/29/2020
Event Type  malfunction  
Event Description
It was reported that during an implant procedure, it was noticed that the inflatable penile prosthesis (ipp) cylinders would not inflate.The cylinder in the right side of the patient appeared to be less inflating than the other side, which was never seen before.It is suspected that there was a piece of debris or particle wedged inside the implant.Multiple cycles were attempted, but the physician did not feel good about implanting the device.Procedure was completed with another of the same device.No patient complications.
 
Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes that the visual inspection of the device did not identify any leaks in the device or any presence of foreign material.The device was functionally tested and all components performed within specification.Based on the testing results, the reported allegations of foreign material and inflation issues were unable to be confirmed.Device history review (dhr).The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.Device analysis: visual inspection of the device did not identify any leaks.The device was functionally tested and all components performed within specifications.Investigation conclusion: based on this investigation, the investigation conclusion code of no problem detected was chosen because the reported events could not be confirmed or substantiated through investigation.Based on the results of this investigation, no escalation is required.
 
Event Description
It was reported that during an implant procedure, it was noticed that the inflatable penile prosthesis (ipp) cylinders would not inflate.The cylinder in the right side of the patient appeared to be less inflating than the other side, which was never seen before.It is suspected that there was a piece of debris or particle wedged inside the implant.Multiple cycles were attempted, but the physician did not feel good about implanting the device.Procedure was completed with another of the same device.No patient complications.
 
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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 Key11231357
MDR Text Key228833039
Report Number2183959-2021-00147
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953009780
UDI-Public00878953009780
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
Report Date 03/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/21/2022
Device Model Number72404232-10
Device Catalogue Number72404232-10
Device Lot Number1000476333
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2021
Initial Date Manufacturer Received 01/11/2021
Initial Date FDA Received01/26/2021
Supplement Dates Manufacturer Received02/15/2021
Supplement Dates FDA Received03/08/2021
Patient Sequence Number1
Patient Age69 YR
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