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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72404233-12
Device Problems Collapse (1099); Failure to Cycle (1142); Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/06/2020
Event Type  malfunction  
Event Description
It was reported that the physician tried and not used ams 700 cx preconnect ms 21 cm pump that prepared and cycled normally at first, but after additional tests, would no longer pump.The bulb would become depressed and would not refilled.He tried doing a manual reset multiple times by holding the deactivation button, and pumping more, but the pump refused to cooperate.He did not feel comfortable implanting that pump.Instead, they opened another ams 700 cx preconnect ms 12 cm pump, and cut the pump off to hook it up to the ams 700 cx 21 cm cylinders.That pump worked as expected with the already implanted cylinders.
 
Manufacturer Narrative
H3, h6, h10 h3 device evaluation: product analysis confirmed a device malfunction based on the identification of a pump functional test failure.The pump failed deflation test (3) which verifies fluid is moving from the cylinder side of the pump to the reservoir side of the pump when the deflation button is not pressed and 4psi of back pressure is applied on the cylinder.Product analysis therefore concluded that this failure would affect the functionality of the device; a device malfunction was identified.
 
Event Description
It was reported that the physician tried and not used ams 700 cx preconnect ms 21 cm pump that prepared and cycled normally at first, but after additional tests, would no longer pump.The bulb would become depressed and would not refilled.He tried doing a manual reset multiple times by holding the deactivation button, and pumping more, but the pump refused to cooperate.He did not feel comfortable implanting that pump.Instead, they opened another ams 700 cx preconnect ms 12 cm pump, and cut the pump off to hook it up to the ams 700 cx 21 cm cylinders.That pump worked as expected with the already implanted cylinders.Additional information received indicated the pump was not cycling well intraop with slow refill and no pop.It was exchanged for new pump intraop with normal functionality.
 
Manufacturer Narrative
Corrected data d5.Additional information b5, d10, h3, h6.
 
Event Description
It was reported that the physician tried and not used ams 700 cx preconnect ms 21 cm pump that prepared and cycled normally at first, but after additional tests, would no longer pump.The bulb would become depressed and would not refilled.He tried doing a manual reset multiple times by holding the deactivation button, and pumping more, but the pump refused to cooperate.He did not feel comfortable implanting that pump.Instead, they opened another ams 700 cx preconnect ms 12 cm pump, and cut the pump off to hook it up to the ams 700 cx 21 cm cylinders.That pump worked as expected with the already implanted cylinders.Additional information received indicated the pump was not cycling well intraop with slow refill and no pop.It was exchanged for new pump intraop with normal functionality.
 
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Brand Name
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
Type of Device
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key9582846
MDR Text Key175418115
Report Number2183959-2020-00044
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953009797
UDI-Public00878953009797
Combination Product (y/n)N
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,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? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2021
Device Model Number72404233-12
Device Catalogue Number72404233-12
Device Lot Number1000351260
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2020
Initial Date Manufacturer Received 01/06/2020
Initial Date FDA Received01/13/2020
Supplement Dates Manufacturer Received01/14/2020
02/14/2020
Supplement Dates FDA Received02/12/2020
02/24/2020
Patient Sequence Number1
Patient Age55 YR
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