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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 3MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION
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STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 3MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION Back to Search Results
Catalog Number M0035473080
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2014
Event Type  malfunction  
Event Description
Resistance was encountered as the coil was advanced into the hub of the microcatheter.As the coil was being removed form the microcatheter, it was noted that the coil broke off and part of the coil remained in the catheter hub.There was no clinical consequence to the patient.
 
Event Description
Resistance was encountered as the coil was advanced into the hub of the microcatheter.As the coil was being removed form the microcatheter, it was noted that the coil broke off and part of the coil remained in the catheter hub.There was no clinical consequence to the patient.
 
Manufacturer Narrative
The device was not available to the manufacturer.
 
Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications. analysis of the returned device revealed that the main coil was broken at the main junction.The delivery wire was bent and the proximal contact was kinked.Based on the investigation and the information available, it is probable that procedural factors limited the performance of the device resulting in the reported event.Therefore, a cause of operational context has been assigned to this event.
 
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Brand Name
TARGET 360 SOFT 3MM X 8CM
Type of Device
DEVICE, NEUROVASCULAR EMBOLIZATION
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
alyson harris
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key4329288
MDR Text Key5137359
Report Number3008853977-2014-00395
Device Sequence Number1
Product Code HCG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093142
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/03/2014
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 Catalogue NumberM0035473080
Device Lot Number15781562
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/27/2015
Initial Date FDA Received12/15/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/03/2015
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 Sequence Number1
Treatment
ECHELLON-10 MICROCATHETER (EV3)
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