MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035476300
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that the subject coil detached during the procedure when an attempt was made to retract it into the microcatheter to reposition the subject coil.No clinical consequences reported to the patient.
Event or Problem Description
It was reported that the subject coil detached during the procedure when an attempt was made to retract it into the microcatheter to reposition the subject coil.No clinical consequences reported to the patient.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject coil device was returned together with the sl-10 microcatheter and un-known guidewire.The sl-10 microcatheter and guidewire were found to be intact.The subject main coil was found to be stretched and detached from the delivery wire and stuck inside the microcatheter due to the dry blood.The coil introducer sheath and the sdw (stent delivery wire) were not returned.An attempt was taken to remove the subject coil from the microcatheter for further analysis.The subject coil device could not be flushed due to dry blood within the microcatheter.The subject coil could not be pushed using returned guidewire.The subject coil was pulled out from the distal end of the microcatheter.The reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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.During analysis, the main coil was found to be stretched and detached from the delivery wire and stuck inside the microcatheter due to dry blood.The delivery wire was not returned.An assignable cause of procedural factors will be assigned to the as reported/as analyzed 'main coil prematurely detached/separated during use' and main coil stretched', as these defects appear to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.

• Brand Name: TARGET 360 SOFT 6MM X 30CM
• Common Device Name: 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 Key: 14602785
• Report Number: 3008881809-2022-00273
• Device Sequence Number: 12290408
• Product Code: HCG
• UDI-Device Identifier: 04546540676559
• UDI-Public: 04546540676559
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2025
• Device Model Number: M0035476300
• Device Catalogue Number: M0035476300
• Device Lot Number: 23504005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/26/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female