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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 Collapse (1099); Deflation Problem (1149); Fluid/Blood Leak (1250); Inflation Problem (1310); Mechanical Problem (1384); Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/24/2020
Event Type  Injury  
Event Description
It was reported that the patient experienced a pumping issue with an inflatable penile prosthesis (ipp).The observed issues were related to inflation issues, sticky pump and the pump staying flat when used.The problems were noticed during routine follow up and it was decided to let it sit for 6 weeks and "see if it fixes".There were no patient complications related to the device.
 
Manufacturer Narrative
Product investigation completed.As the complaint component was not returned for analysis, no product analysis could be performed.The reported allegations could not be confirmed.
 
Event Description
It was reported that the patient experienced a pumping issue with an inflatable penile prosthesis (ipp).The observed issues were related to inflation issues, deflation issues, sticky pump and the pump staying flat when used.The problems were noticed during routine follow up and it was decided to let it sit for 6 weeks and "see if it fixed".Around two months later the device did not inflate.The patient underwent a replacement surgery to remove and replace the pump.During the procedure fluid loss was noted.There were no patient complications related to the device.
 
Manufacturer Narrative
B5, h2, h6, h9, h10 updated.
 
Event Description
It was reported that the patient experienced a pumping issue with an inflatable penile prosthesis (ipp).The observed issues were related to inflation issues, sticky pump and the pump staying flat when used.It was also indicated that initially the device only partially inflated but it would not deflate.The problems were noticed during routine follow up and it was decided to let it sit for 6 weeks and "see if it fixes".There were no patient complications related to the device.
 
Manufacturer Narrative
Product investigation completed.The pump was visually inspected; no leaks were found.The foreign material (fm) was found inside pump.Based on the visual inspection, this fm was concluded to likely be contaminate from the patient.The fm was unable to be removed from the pump and further analyzed.The pump was functionally tested to confirm the functionality and failed the 8lb.Activation test.The pump therefore required more than 8lbs.Of force to activate.Product analysis was unable to confirm the reported events related to fluid loss but confirmed pump malfunction.Product investigation completed.As the complaint component was not returned for analysis, no product analysis could be performed.The reported allegations could not be confirmed.
 
Event Description
It was reported that the patient experienced a pumping issue with an inflatable penile prosthesis (ipp).The observed issues were related to inflation issues, deflation issues, sticky pump and the pump staying flat when used.The problems were noticed during routine follow up and it was decided to let it sit for 6 weeks and "see if it fixed".Around two months later the device did not inflate.The patient underwent a replacement surgery to remove and replace the pump.During the procedure fluid loss was noted.There were no patient complications related to the device.
 
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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 Key10697084
MDR Text Key211947730
Report Number2183959-2020-04818
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
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 01/24/2021
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 Date12/14/2021
Device Model Number72404232-10
Device Catalogue Number72404232-10
Device Lot Number1000371639
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2020
Initial Date Manufacturer Received 09/24/2020
Initial Date FDA Received10/19/2020
Supplement Dates Manufacturer Received11/09/2020
11/18/2020
01/06/2021
Supplement Dates FDA Received11/20/2020
12/04/2020
01/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberRES# 86562
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age57 YR
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