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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 150CM 2 TIP CATHETER, PERCUTANEOUS

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STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 150CM 2 TIP CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number M0031681890
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem Thrombosis (2100)
Event Date 05/18/2015
Event Type  Injury  
Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications. Visual and microscopic inspection of the returned device found that the catheter shaft had a slight bend. Blood was noted within the catheter hub. The proximal and distal marker bands were confirmed to be present with no anomalies. Friction was noted during a patency test due to blood within the microcatheter. The device was unable to be flushed due to dried blood within the catheter. The device was soaked for 5 minutes after which it was flushed, blood exited the distal end. A demonstration synchro 0. 014¿ guide wire was advanced through the catheter without difficulty. Based the device analysis both the proximal and the distal radiopaque markers were present on the microcatheter; therefore the reported event of the catheter proximal radiopaque marker missing was not confirmed. The risk of thrombosis, which caused a distal occlusion of the posterior communication artery, is a known and anticipated complication to these types of procedures and is noted in the labeling. Therefore, it was determined that the reported event was an anticipated procedural complication.
 
Event Description
It was reported that during a coil embolization of the basilar tip aneurysm, it was hard to see if the coil was fully outside the microcatheter due to poor visibility of the catheter proximal radiopaque marker and therefore, it was hard to identify if the coil was ready to be detached. The physician stated that this resulted in a thrombus may has been inadvertently pulled out of the aneurysm while the physician was manipulating and repositioning the coil and caused a distal occlusion of the posterior communication artery. Medical management (not specified) to treat the complication was provided. No further details are available.
 
Event Description
It was reported that during a coil embolization of the basilar tip aneurysm, it was hard to see if the coil was fully outside the microcatheter due to poor visibility of the catheter proximal radiopaque marker and therefore, it was hard to identify if the coil was ready to be detached. The physician stated that this resulted in a thrombus may has been inadvertently pulled out of the aneurysm while the physician was manipulating and repositioning the coil and caused a distal occlusion of the posterior communication artery. Medical management (not specified) to treat the complication was provided. No further details are available.
 
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Brand NameEXCELSIOR SL-10 150CM 2 TIP
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer Contact
kathleen shin
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key4839040
MDR Text Key23394521
Report Number3008853977-2015-00243
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013789
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 05/18/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/23/2017
Device Catalogue NumberM0031681890
Device Lot Number18307251
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/28/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/11/2015 Patient Sequence Number: 1
Treatment
SYNCHRO GUIDEWIRE (STRYKER); TARGET COILS (STRYKER_NUMBER UNKNOWN)
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