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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 72404292
Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/04/2021
Event Type  Injury  
Event Description
It was reported the inflatable penile prosthesis (ipp) did not work as expected, so the patient went to the hospital two weeks before the surgery.Patient underwent a surgical procedure in which all components were explanted and replaced.Upon explant, it was confirmed that there was a saline leakage from the pump due to a crack in the pump connecting pipe.The cause of the pump connecting tube crack has not been identified by the hospital.After this operation, the patient improved and he remains stable after procedure.
 
Event Description
It was reported the inflatable penile prosthesis (ipp) did not work as expected, so the patient went to the hospital two weeks before the surgery.Patient underwent a surgical procedure in which all components were explanted and replaced.Upon explant, it was confirmed that there was a saline leakage from the pump due to a crack in the pump connecting pipe.The cause of the pump connecting tube crack has not been identified by the hospital.After this operation, the patient improved and he remains stable after procedure.
 
Manufacturer Narrative
Investigation summary with all the available information, boston scientific concludes that the visual examination identified leaks in the kink resistant tubing (krt) attributed to fatigue.The device also failed functional test for activation.Based on this findings, the reported allegations are confirmed.Device history records (dhr) the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis visual analysis of the device identified leaks in the kink resistant tubing (krt) attributed to fatigue and worn to filament; holes were present.Functional test of the device showed that the pump failed activation test that verifies that with the pump in the deactive state, fluid does move from the reservoir side of the pump to the cylinder side of the pump through a squeezing motion of the pump bulb at less than 8 lbf with no back pressure on the cylinder to the pump.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.Investigation conclusion based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.
 
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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 Key11265690
MDR Text Key229825742
Report Number2183959-2021-00257
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953003948
UDI-Public00878953003948
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,o
Type of Report Initial,Followup
Report Date 03/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/03/2020
Device Model Number72404292
Device Catalogue Number72404292
Device Lot Number921712003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2021
Date Manufacturer Received03/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
72404161/913124017; 72404161/913124017; 72404161/913124017
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age70 YR
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