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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 72404156
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Internal Organ Perforation (1987)
Event Date 04/16/2021
Event Type  Injury  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the patient had the inflatable penile prosthesis removed as it was not possible to activate/inflate the device due to fluid loss.During the surgery, an iatrogenic lesion of the neobladder occurred.The lesion was a perforation of the neobladder that occurred during the device explant.This led to an additional incision and neobladder repair.Due to his permanent anticoagulation, the patient also revealed a massive scrotal hematoma.It was expected that the recovery would take more time as usual.Refer to mfr report number 2183959-2021-13938.
 
Event Description
It was reported that the patient had the inflatable penile prosthesis removed as it was not possible to activate/inflate the device due to fluid loss.During the surgery, an iatrogenic lesion of the neobladder occurred.The lesion was a perforation of the neobladder that occurred during the device explant.This led to an additional incision and neobladder repair.Due to his permanent anticoagulation, the patient also revealed a massive scrotal hematoma.It was expected that the recovery would take more time as usual.Refer to mfr report number 2183959-2021-13938.
 
Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes, based on analysis results, the cause that contributed to the reported that the neobladder was perforated was not confirmed.Product analysis was unable to confirm the reported event.Device history record review (dhr): the device history record review (dhr) confirmed the device met all manufacturing specifications, a risk review confirmed that the event is accounted for in the risk documentation.Label review: a labeling review found no evidence of device off-label use or failure to follow instructions.Device technical analysis: upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The ams700 spherical reservoir was visually inspected, leak tested and microscopically examined; no visual damages were found upon inspection.Under the microscope, the reservoir had wear at a fold in the reservoir shell; no leak was found in the reservoir shell.This wear would not affect the functionality of the device.Product analysis was unable to confirm the reported event.Investigation conclusion: based on this investigation a clear probable cause for the event was not established; therefore, the conclusion code of adverse event related to procedure was chosen because the reported events could not be confirmed or substantiated through investigation.
 
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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
300 boston scientific way
marlborough MA 01752
MDR Report Key11828931
MDR Text Key250757921
Report Number2124215-2021-13939
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953003214
UDI-Public00878953003214
Combination Product (y/n)Y
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 06/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/23/2015
Device Model Number72404156
Device Catalogue Number72404156
Device Lot Number854145007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2021
Date Manufacturer Received05/18/2021
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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