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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 Failure to Cycle (1142); Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/11/2019
Event Type  Injury  
Manufacturer Narrative
Device not returned for evaluation.
 
Event Description
It was reported that due to the patient unable to utilize his device due to inflation issues from pump not transferring fluid into the cylinders, the patient had his inflatable penile prosthesis (ipp) removed and replaced.The ipp was explanted and a new device consisting of cylinders, pump and reservoir were implanted.No patient issues were reported in relation to this surgery.
 
Manufacturer Narrative
An allegation of an inflation issue was reported.The ams700 ipp cylinders were visually inspected and functionally tested.Cylinder 1 had multiple leaks in the cylinder body attributed to input tube wear along with fatigue and wear at the corner of a buckling fold.The kink resistant tubing was worn to the filament and the input tube sleeve measured approximately 21mm.Cylinder 2 performed within specification.The ams 700 momentary squeeze (ms) pump was visually inspected.The krt was also worn to the filament; however, no leaks were identified.The pump was functionally tested and failed the deflation test.Product analysis confirmed device malfunctions which would affect the functionality of the device and could result in an inflation issue.Correction to h2, h3, and h6: updated to include device analysis.
 
Event Description
It was reported that due to the patient unable to utilize his device due to inflation issues from pump not transferring fluid into the cylinders, the patient had his inflatable penile prosthesis (ipp) removed and replaced.The ipp was explanted and a new device consisting of cylinders, pump and reservoir were implanted.No patient issues were reported in relation to this surgery.
 
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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 Key9559162
MDR Text Key173964659
Report Number2183959-2019-68532
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
Report Date 02/24/2020
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 Manufacturer01/23/2020
Initial Date Manufacturer Received 12/15/2019
Initial Date FDA Received01/07/2020
Supplement Dates Manufacturer Received02/21/2020
Supplement Dates FDA Received02/24/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age64 YR
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