MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035442040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an aneurysm coiling procedure was performed in a patient.During the procedure a microcatheter was used to reach the target lesion.The subject coil was the first coil which was attempted to be delivered through the microcatheter to the target lesion.When advancing the subject coil through the microcatheter, the subject coil detached prematurely into the lumen of the microcatheter.When the successive second and third coil were attempted to be inserted into the same microcatheter without noticing the prematurely detached first subject coil, the successive coil's could not be introduced into the microcatheter.The subject coil along with the microcatheter were retrieved out of the patient's body.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection: the main coil was found to be detached and not returned.The detachment seems to be mechanical.The coil delivery wire was found to be kinked/bent.Functional inspection: not applicable.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.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the tapered distal end of the introducer sheath was firmly seated in the hub of the microcatheter, no torque was given where advancing the delivery wire, and the coil was advanced slowly and gently without applying excessive force.During analysis, the main coil was found to be detached from the delivery wire and was not returned.Based on visual inspection, the detachment appeared to be mechanical in nature.The returned delivery wire was found to be kinked/bent.An assignable cause of procedural factors will be assigned to the as reported/as analyzed (ar/aa) 'main coil prematurely detached/separated during use' since this issue appears 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.An assignable cause of handling damage will be assigned to the as analyzed (aa) 'coil delivery wire kinked/bent' since this issue is associated with handling of the device during the clinical procedure, upon removal of the device from the packaging, or preparation of the device prior to use.
Event or Problem Description
It was reported that an aneurysm coiling procedure was performed in a patient.During the procedure a microcatheter was used to reach the target lesion.The subject coil was the first coil which was attempted to be delivered through the microcatheter to the target lesion.When advancing the subject coil through the microcatheter, the subject coil detached prematurely into the lumen of the microcatheter.When the successive second and third coil were attempted to be inserted into the same microcatheter without noticing the prematurely detached first subject coil, the successive coil's could not be introduced into the microcatheter.The subject coil along with the microcatheter were retrieved out of the patient's body.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 NANO 2MM X 4CM
• 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: 12883884
• Report Number: 3008881809-2021-00496
• Device Sequence Number: 4918307
• Product Code: HCG
• UDI-Device Identifier: 07613252600299
• UDI-Public: 07613252600299
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/25/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/18/2023
• Device Model Number: M0035442040
• Device Catalogue Number: M0035442040
• Device Lot Number: 22373939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 02/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SL- 10 MICROCATHETER (STRYKER)
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian