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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 72404281
Device Problems Collapse (1099); Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 06/11/2020
Event Type  Injury  
Event Description
It was reported that the patient had a pump replacement surgery due to a dimpled pump with his inflatable penile prosthesis (ipp).
 
Manufacturer Narrative
Correction to h2, h3, and h6: updated to include device analysis.Product analysis summary product analysis confirmed the reported event related to pump collapse and mechanical issue.The ams 700 momentary squeeze (ms) pump was visually inspected.The kink resistant tubing (krt) was worn to the filament; however, no leaks were present.The pump was functionally tested and failed activation test.Product analysis concluded that identified a pump failed activation test was the most probable cause of the device malfunction.Dhr review / similar complaint review of manufacturing documentation was performed to ensure that all required in-process and final inspections and testing were completed.Review of the manufacturing records for batch 1000002554 and it respective container 21289053, found no evidence that the device failed to meet applicable product specifications prior to shipment from boston scientific.There is no evidence that the reported events are related to a manufacturing deficiency based on the product analysis and a review of the manufacturing records.Additionally, potential emerging trends are captured as part of the post market signal evaluation and escalation process.Risk review the ams 700 hazard analysis indicates that the as reported events of this complaint do not represent a new hazardous situation.Additionally, boston scientific does not have responsibility to provide training to medical professional as documented in the dfu/ifu, and the ams 700 is not a new product because it is not within the first six months of its release in any geography, and it is not a new design platform.No further review is required.
 
Event Description
It was reported that the patient had a pump replacement surgery due to a dimpled pump with his inflatable penile prosthesis (ipp).It was added that the pump did not work and was "freezing" when trying to use it.The patient was experiencing these problems with the pump and also pain prompting him to see his physician.The onset of these issues was (b)(6)2020.The patient outcome following this surgery was "not bad.".
 
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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 Key10236434
MDR Text Key197679042
Report Number2183959-2020-02814
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953003849
UDI-Public00878953003849
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
Type of Report Initial,Followup
Report Date 07/22/2020
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 Expiration Date11/30/2022
Device Model Number72404281
Device Catalogue Number72404281
Device Lot Number1000002554
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2020
Initial Date Manufacturer Received 06/11/2020
Initial Date FDA Received07/06/2020
Supplement Dates Manufacturer Received07/19/2020
Supplement Dates FDA Received07/22/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age60 YR
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