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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY FLOWGATE2 8F X 85CM; CATHETER, PERCUTANEOUS
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STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY FLOWGATE2 8F X 85CM; CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number 90485
Device Problem Material Perforation (2205)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/04/2019
Event Type  malfunction  
Manufacturer Narrative
Subject device is not available.
 
Event Description
It was reported that during the procedure, the physician encountered difficulty while inserting the subject balloon guide catheter into the sheath.The physician pulled out the balloon guide catheter and tried inflating it outside the patient anatomy and confirmed that the balloon was broken.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
 
Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.Information available indicated that the device was prepared as per directions for use (dfu) and continuous flush was maintained.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned for analysis, a cause of undeterminable was assigned.
 
Event Description
It was reported that during the procedure, the physician encountered difficulty while inserting the subject balloon guide catheter into the sheath.The physician pulled out the balloon guide catheter and tried inflating it outside the patient anatomy and confirmed that the balloon was broken.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
 
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Brand Name
FLOWGATE2 8F X 85CM
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
4870 west 2100 south
salt lake city UT 84120
MDR Report Key8951729
MDR Text Key193626648
Report Number0002954917-2019-00006
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K153729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 10/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/13/2020
Device Catalogue Number90485
Device Lot Number16456
Was Device Available for Evaluation? No
Date Manufacturer Received09/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CHIKAI GUIDEWIRE (NON STRYKER)
Patient Age71 YR
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