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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS AMBICOR PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC

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BOSTON SCIENTIFIC CORPORATION AMS AMBICOR PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number UNK-P-APP
Device Problems Inflation Problem (1310); Mechanical Problem (1384)
Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Event Date 12/03/2020
Event Type  Injury  
Event Description
It was reported that inflatable penile prosthesis (ipp) right cylinder failed and patient had deviation in penis.All components were explanted and replaced.
 
Manufacturer Narrative
The complaint component was returned and analyzed, and the reported allegations of inflation issue and mechanical issue were confirmed via product analysis.The ambicor cylinders, pump and tubing were visually inspected.Both cylinders had leak in proximal cylinder body that was the result of sharp instrument damage consistent with explant damage; hole was present.Due to this damage being consistent with explant it will be considered a secondary failure.Both cylinders had broken fabric treads in cylinder body attributed to fatigue and wear at fold.The kink resistance tubing (krt) was fatigue and worn to the filament; no leak was found.No damage was identified in relation to the pump.However, product analysis concluded that identified broken fabric treads in the cylinder was the most probable cause of the reported events.Based on this investigation, the investigation conclusion code of cause traced to component failure was chosen because the reported events could be traced to a component failure.Based on the results of this investigation, no escalation is required.
 
Event Description
It was reported that inflatable penile prosthesis (ipp) right cylinder failed and patient had deviation in penis.All components were explanted and replaced.
 
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Brand Name
AMS AMBICOR PENILE PROSTHESIS
Type of Device
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key11097803
MDR Text Key224516484
Report Number2183959-2020-06183
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 distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 02/18/2021
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-APP
Device Catalogue NumberUNK-P-APP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2021
Initial Date Manufacturer Received 12/15/2020
Initial Date FDA Received12/30/2020
Supplement Dates Manufacturer Received01/28/2021
Supplement Dates FDA Received02/18/2021
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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