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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR SYNCHRO 10; WIRE, GUIDE, CATHETER
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STRYKER NEUROVASCULAR SYNCHRO 10; WIRE, GUIDE, CATHETER Back to Search Results
Model Number M00316310
Device Problems Break (1069); Difficult To Position (1467)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/18/2018
Event Type  Injury  
Event Description
Navigating vessel of interest, the wire stopped moving, as the md pulled back on the wire the tip remained unchanged in its position.Identified the broken wire.Manufacturer response for a synchro 10 neuro guidewire with hydrophillic coating, synchro (per site reporter).Requested additional detailed information.
 
Event Description
Navigating vessel of interest, the wire stopped moving, as the md pulled back on the wire the tip remained unchanged in its position.Identified the broken wire.Manufacturer response for a synchro 10 neuro guidewire with hydrophillic coating, synchro (per site reporter).Requested additional detailed information.
 
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Brand Name
SYNCHRO 10
Type of Device
WIRE, GUIDE, CATHETER
Manufacturer (Section D)
STRYKER NEUROVASCULAR
47900 bayside parkway
fremont CA 94538
MDR Report Key7645366
MDR Text Key112581815
Report Number7645366
Device Sequence Number1
Product Code DQX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00316310
Device Catalogue Number1631
Device Lot Number0000007207
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/21/2018
Date Report to Manufacturer06/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age21535 DA
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