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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 Problem Inflation Problem (1310)
Patient Problem Internal Organ Perforation (1987)
Event Date 02/06/2019
Event Type  Injury  
Event Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) replacement surgery because the cylinders were not inflating properly during pumping.The existing cylinders and pump components were explanted and replaced.The existing reservoir was drained of its fluid but remained implanted in the patient.The surgeon attempted to implant a replacement reservoir on the side opposite to that of the existing reservoir.During this attempt, the surgeon observed some blood on the catheter as it was being retracted.The surgeon subsequently reported a small bladder injury caused by the replacement reservoir.The replacement reservoir was then removed, and the tubing to the replacement pump and cylinders was plugged.No other patient complications were reported during the procedure.The patient was reported to be doing well at the end of the procedure.A future surgery to implant another reservoir was planned after the patient had healed from the bladder injury.The explanted ipp components are expected to be returned.A supplemental report will be filed upon completion of the product analysis.
 
Event Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) replacement surgery because the cylinders were not inflating properly during pumping.The existing cylinders and pump components were explanted and replaced.The existing reservoir was drained of its fluid but remained implanted in the patient.The surgeon attempted to implant a replacement reservoir on the side opposite to that of the existing reservoir.During this attempt, the surgeon observed some blood on the catheter as it was being retracted.The surgeon subsequently reported a small bladder injury caused by the replacement reservoir.The replacement reservoir was then removed, and the tubing to the replacement pump and cylinders was plugged.No other patient complications were reported during the procedure.The patient was reported to be doing well at the end of the procedure.A future surgery to implant another reservoir was planned after the patient had healed from the bladder injury.The explanted ipp components were returned for analysis.
 
Manufacturer Narrative
The ams700 device was inspected and functionally tested.There was a leak in one cylinder due to tool damage consistent with explant damage.The other cylinder had a leak due to fold wear.The pump was not functionally tested due to the cylinder failure.The pump kink resistant tubing (krt) was worn to the filament.Both cylinders had buckling folds.An overall investigation conclusion code of "cause traced to component failure" was chosen as the analysis findings and event are an expected or random component failure without any design or manufacturing issue.See external support request form (b)(4).No escalation to ncep, capa, or scar is required, complaints are monitored for escalation of systemic issues through the trending process per the cis product investigation work instruction (windchill document # (b)(4)).
 
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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 Key8402120
MDR Text Key138208703
Report Number2183959-2019-61391
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 health professional
Type of Report Initial,Followup
Report Date 04/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2019
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 Manufacturer02/27/2019
Date Manufacturer Received04/29/2019
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age68 YR
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