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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 2MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION
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STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 2MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION Back to Search Results
Model Number M0036122030
Device Problem Inadequate User Interface (2958)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/31/2021
Event Type  malfunction  
Manufacturer Narrative
The device is not available to the manufacturer.
 
Event Description
It was reported that during the procedure when the physician was repeatedly inserting and removing the subject coil in and out of the microcatheter to place to the target area, the middle part of the coil subject device was not visible and on retrieval the subject coil was found stretched.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
 
Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The product was not returned for analysis therefore, visual and functional testing was not performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Additional information received indicated that there was friction or resistance while the coil was advancing in the introducer sheath which may have damaged the coil.Also additional information received indicated that continuous flush was not maintained throughout the procedure, as per the dfu continuous flush is required during the procedure.An assignable cause of user error will be assigned to this complaint as the investigation confirms that there was an act or omission of an act that resulted in a different medical product response than intended by the manufacturer and/or expected by the user.
 
Event Description
It was reported that during the procedure when the physician was repeatedly inserting and removing the subject coil in and out of the microcatheter to place to the target area, the middle part of the coil subject device was not visible and on retrieval the subject coil was found stretched.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
 
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Brand Name
TARGET XL 360 SOFT 2MM X 3CM
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 Key13387370
MDR Text Key284682141
Report Number3008881809-2022-00041
Device Sequence Number1
Product Code HCG
UDI-Device Identifier07613327128321
UDI-Public07613327128321
Combination Product (y/n)N
Reporter Country CodeJA
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,Followup
Report Date 04/25/2022
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 Expiration Date08/15/2024
Device Model NumberM0036122030
Device Catalogue NumberM0036122030
Device Lot Number23100857
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/05/2022
Initial Date FDA Received01/28/2022
Supplement Dates Manufacturer Received03/30/2022
Supplement Dates FDA Received04/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/17/2021
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
MICROCATHETER (UNKNOWN)
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