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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 72404231
Device Problems Collapse (1099); Fluid/Blood Leak (1250); Inflation Problem (1310)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/28/2019
Event Type  Injury  
Manufacturer Narrative
Medical device: model number/catalog number 720185-01, serial number (b)(4), batch/lot number 151513011, gtin (b)(4), description reservoir flat iz 100 ml, expiration date 09/29/2018, medical device: manufacturer date 10/19/2016.
 
Event Description
It was reported that the patient had the inflatable penile prosthesis removed due to the right cylinder failing to inflate properly upon activation.When activated, the pump also appeared misshapen within the patients scrotum.The reservoir was found during the procedure to contain significantly less fluid than it had been filled with.A new inflatable penile prosthesis consisting of cylinders, pump, and reservoir were implanted.Additional information received indicated that the leak was unknown at time of surgery, all that was found was that there was only a small volume of saline left in the system and that the pump was depressed when the device was activated.
 
Event Description
It was reported that the patient had the inflatable penile prosthesis removed due to the right cylinder failing to inflate properly upon activation.When activated, the pump also appeared misshapen within the patients scrotum.The reservoir was found during the procedure to contain significantly less fluid than it had been filled with.A new inflatable penile prosthesis consisting of cylinders, pump, and reservoir were implanted.Additional information received indicated that the leak was unknown at time of surgery, all that was found was that there was only a small volume of saline left in the system and that the pump was depressed when the device was activated.
 
Manufacturer Narrative
Device analysis: returned product consisted of cx preconnect ms 15cm ps iz.The device passed functional testing and did not have any damage.The reported device failure was not confirmed.Based on a lack of damage on the returned device and the successful functional test, the most probable cause for this complaint was considered no problem detected.This complaint investigation conclusion code is utilized when the device complaint or problem cannot be confirmed.Based on the results of this investigation, no escalation is necessary.D4 model number/catalog number 720185-01.Serial number (b)(6).Batch/lot number 151513011.Gtin 878953005669.Description reservoir flat iz 100 ml.Expiration date 09/29/2018.H4 manufacturer date 10/19/2016.
 
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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 Key8727471
MDR Text Key148968650
Report Number2183959-2019-64509
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953003443
UDI-Public00878953003443
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 07/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/20/2018
Device Model Number72404231
Device Catalogue Number72404231
Device Lot Number0130935004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2019
Date Manufacturer Received07/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age51 YR
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