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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 72404252
Device Problems Inflation Problem (1310); Mechanical Problem (1384)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 08/23/2021
Event Type  Injury  
Event Description
It was reported that the inflatable penile prosthesis (ipp) device has failed.The patient states that one day, he noticed bleeding from his penis and when he tried to use his device, it just seized up and would not inflate.The patient has seen his urologist and a replacement surgery has been scheduled for (b)(6) 2021.No further information was provided.
 
Event Description
It was reported that the inflatable penile prosthesis (ipp) device has failed.The patient states that one day, he noticed bleeding from his penis and when he tried to use his device, it just seized up and would not inflate.The patient has seen his urologist and a replacement surgery has been scheduled for 26aug2021.No further information was provided.
 
Manufacturer Narrative
Investigation summary: based on the information available, boston scientific concludes that the cause that contributed to the reported event cannot be established as the product is not available for analysis.Device history record review: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.There is no objective evidence that the user did not properly handle or use the device according to the ams 700 instructions for use (ifu).The ams 700 ifu lists bleeding, as a potential adverse event associated with implant of this device.Investigation conclusion: based on the information available, a conclusion code of cause not established was assigned to this investigation.
 
Manufacturer Narrative
There was no device available for analysis.The reported patient symptoms are known risk associated with implants of these device as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
 
Event Description
It was reported that the inflatable penile prosthesis (ipp) device has not performed as expected.The patient states that one day, he noticed bleeding from his penis and when he tried to use his device, it just seized up and would not inflate.The patient had been scheduled for several revision surgeries but canceled due to health issues.No further information was provided.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer Contact
alyson harris
4100 hamline avenue north
building c
saint paul, MN 55112
4089353452
MDR Report Key12473845
MDR Text Key271452807
Report Number2124215-2021-27826
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953003603
UDI-Public00878953003603
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 11/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date06/09/2018
Device Model Number72404252
Device Catalogue Number72404252
Device Lot Number0137448001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
RESERVOIR: UPN 72404155/ LOT 151103020.; RESERVOIR: UPN 72404155/ LOT 151103020.; RESERVOIR: UPN 72404155/ LOT 151103020.; RESERVOIR: UPN 72404155/ LOT 151103020
Patient Outcome(s) Other;
Patient Age60 YR
Patient SexMale
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