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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 UNK-P-IPP
Device Problems Failure to Cycle (1142); Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/12/2020
Event Type  Injury  
Event Description
It was reported that the patient was not able to cycle an inflatable penile prosthesis (ipp).A replacement surgery was performed in which the existing ipp was removed and a new tactra penile prosthesis was implanted.Upon removal of the previous system it was noted that it had no fluid.The patient did not experience any adverse event and fully recovered following the procedure.
 
Manufacturer Narrative
Product investigation completed.The cylinders were visually inspected and functionally tested.Both cylinders had leak in proximal cylinder body attributed to sharp instrument damage which mostly occurred during the explant.Holes with tool marking were present.Due to this damage being consistent with explant it will be considered a secondary failure.Both cylinders had fold that indicate possible buckling of the cylinders in the proximal cylinder body.Both cylinders had wear at fold in cylinder body.This wear would not affect the functionality of device.The reservoir was visually inspected and functionally tested.The reservoir has wear at fold in the reservoir shell; no leak was found.The pump was visually inspected and functionally tested; pump performed within specification.Product analysis was unable to confirm the reported events.Based on the results of this investigation, no escalation is required.
 
Event Description
It was reported that the patient was not able to cycle an inflatable penile prosthesis (ipp).A replacement surgery was performed in which the existing ipp was removed and a new tactra penile prosthesis was implanted.Upon removal of the previous system it was noted that it had no fluid.The patient did not experience any adverse event and fully recovered following the procedure.
 
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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 Key10760170
MDR Text Key213840257
Report Number2183959-2020-05245
Device Sequence Number1
Product Code FHW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 11/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberUNK-P-IPP
Device Catalogue NumberUNK-P-IPP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2020
Date Manufacturer Received11/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age67 YR
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