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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 9MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION
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STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 9MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION Back to Search Results
Catalog Number M0036129300
Device Problems Fracture (1260); Premature Activation (1484)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/10/2024
Event Type  Injury  
Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
 
Event Description
It was reported that during middle cerebral artery ruptured aneurysm coiling procedure, the physician noticed that the subject coil loop was obstructing flow into the vessel prior to the deployment.Physician decided to pull the subject coil out and resheath it.While withdrawing, the subject coil stretched, broke and detached prematurely within the microcatheter.The physician pulled the microcatheter and intermediate catheter out.Half of the subject coil was in the aneurysm the other half was outside the aneurysm from middle cerebral artery to cervical internal carotid artery.Physician attempted to retrieve the broken coil using a stent retriever and a micro snare kit, however, failed to do so.Physician decided to leave the broken subject coil inside patient as it was not flow obstructing at the end of the procedure.During the retrieval process some pieces of the broken coil were pulled out of the catheters.Additional medication was given to the patient.
 
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Brand Name
TARGET XL 360 SOFT 9MM X 30CM
Type of Device
DEVICE, NEUROVASCULAR EMBOLIZATION
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI  NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI   NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key18633977
MDR Text Key334492661
Report Number3008881809-2024-00040
Device Sequence Number1
Product Code HCG
UDI-Device Identifier04546540711618
UDI-Public04546540711618
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 02/02/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberM0036129300
Device Lot Number24484456
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/11/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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
EXCELSIOR SL 10 MICROCATHETER (STRYKER); INTERMEDIATE CATHETER (UNKNOWN); MICRO SNARE KIT (UNKNOWN); TREVO STENT RETRIEVER (STRYKER)
Patient Outcome(s) Required Intervention; Other;
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