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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.

 
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Brand NameFLOWGATE2 8F X 85CM
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
4870 west 2100 south
salt lake city UT 84120
Manufacturer (Section G)
STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
4870 west 2100 south
salt lake city UT 84120
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key8951729
MDR Text Key193626648
Report Number0002954917-2019-00006
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
PMA/PMN NumberK153729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/10/2019
1 Device Was Involved in the Event
0 PatientS WERE 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
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/15/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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