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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 4 MM X 15 CM; DEVICE, NEUROVASCULAR EMBOLIZATION
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STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 4 MM X 15 CM; DEVICE, NEUROVASCULAR EMBOLIZATION Back to Search Results
Catalog Number M0035434150
Device Problem Premature Activation (1484)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/15/2017
Event Type  Injury  
Event Description
It was reported that during the coil embolization procedure, the coil was prematurely detached inside the microcatheter.The detached coil was aspirated using 5cc syringe and was removed from the patient.The procedure was continued with another new coil.There were no clinical consequences reported to the patient.
 
Manufacturer Narrative
Device evaluated by mfg/summary attached: updated.Expiration date: added.Manufacturing date: added.The device history record review confirms that the device met all material, assembly and performance specifications.Analysis of the returned device revealed that the proximal contact and delivery wire were kinked likely due to handling.The detachment zone was inspected and the main coil appears to have detached due to a physical break at the detachment zone.The main coil was not returned for inspection.Functional testing could not be performed due to the condition of the returned device.Information available indicated that the coil was confirmed to be in good condition after unpacking and preparation and there is no indication of a use error.The anatomy was noted to be tortuous which may have contributed to the reported event.Therefore an assignable cause of operational context has been assigned to this investigation.
 
Event Description
It was reported that during the coil embolization procedure, the coil was prematurely detached inside the microcatheter.The detached coil was aspirated using 5cc syringe and was removed from the patient.The procedure was continued with another new coil.There were no clinical consequences reported to the patient.
 
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Brand Name
TARGET HELICAL ULTRA 4 MM X 15 CM
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
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key7111267
MDR Text Key94620827
Report Number3008881809-2017-00514
Device Sequence Number1
Product Code HCG
Combination Product (y/n)N
PMA/PMN Number
K112385
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 01/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2020
Device Catalogue NumberM0035434150
Device Lot Number19921003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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