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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 Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/27/2019
Event Type  Injury  
Event Description
It was reported that the inflatable penile prosthesis (ipp) device is going to be replaced on (b)(6) 2020 due to fluid loss in the system.The patient reported that the device stopped working sometime during 2018.He was seen by the physician on (b)(6) 2019 to schedule his replacement surgery.
 
Manufacturer Narrative
Additional information b1, b2, b5, h1, h6.
 
Event Description
It was reported that the inflatable penile prosthesis (ipp) device is going to be replaced on (b)(6) 2020 due to fluid loss in the system.The patient reported that the device stopped working sometime during 2018.He was seen by the physician on (b)(6) 2019 to schedule his replacement surgery.Additional information received indicated the fluid leak occurred at a break in the tubing between the pump and one cylinder.There was also signs of significant similar wear on the exact location on the tube on the second side.The leak was definitely due to a hole.
 
Manufacturer Narrative
Additional information b1, b2, b5, h1, h6.D10, h3, h6, h10.H3 device evaluation.The ams700 ipp cylinders were visually inspected and functionally tested.There was a leak in cylinder 1 near the distal end of the cylinder body that was the result of sharp instrument/tool damage consistent with explant damage.Due to this damage being consistent with explant it will be considered a secondary failure.Cylinder 2 had multiple holes in the outer tube attributed to wear at buckling folds; however, no leaks were present.This cylinder did not have an input tube sleeve present.The ams 700 spherical reservoir was visually inspected and functionally tested; no leaks were found.The reservoir therefore performed within specification.The ams 700 momentary squeeze (ms) pump was visually inspected.A leak was identified at the pump strain relief krt cylinder junction attributed to fatigue and wear.The krt was worn to the filament.The pump was unable to be functionally tested due to the leak identified as well as pump contamination present.Product analysis confirmed the fluid leak allegation.
 
Event Description
It was reported that the inflatable penile prosthesis (ipp) device is going to be replaced on (b)(6) 2020 due to fluid loss in the system.The patient reported that the device stopped working sometime during 2018.He was seen by the physician on (b)(6) 2019 to schedule his replacement surgery.Additional information received indicated the fluid leak occurred at a break in the tubing between the pump and one cylinder.There was also signs of significant similar wear on the exact location on the tube on the second side.The leak was definitely due to a hole.
 
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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 Key9581080
MDR Text Key175428134
Report Number2183959-2019-68632
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 foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 03/02/2020
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 Model NumberUNK-P-IPP
Device Catalogue NumberUNK-P-IPP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2020
Initial Date Manufacturer Received 12/16/2019
Initial Date FDA Received01/13/2020
Supplement Dates Manufacturer Received01/29/2020
02/28/2020
Supplement Dates FDA Received01/30/2020
03/02/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age73 YR
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