MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 4MM X 12CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036124120
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer, as device is implanted in patient.
Event or Problem Description
It was reported that a coil embolization procedure was performed in pediatrics for mapca (major aortopulmonary collateral arteries) case.During the procedure during embolization of targeted artery while advancement of the subject coil from tip of the microcatheter to the targeted site, subject coil detached prematurely in the non-stryker microcatheter and with a subject coil delivery wire the physician pushed,the prematurely detached subject coil to the targeted site.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 (manufacturing execution system) there are controls in the manufacturing process to ensure the product met specifications upon release.On investigation, the device was received and the reported lot number was not confirmed as the packaging was not returned with the device.On visual/microscopic inspection, the coil delivery wire was seen to be kinked.The delivery wire was returned with the coil detached.There was no coil returned.Functional test not carried out as the coil had already detached and coil was not returned.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, a non-stryker microcatheter (piolax / lighthouse) was used, the premature detachment occurred while advancing the coil from the tip of the microcatheter to the targeted site, and the coil delivery wire was used to push the detached coil to the coil mass to successfully complete the procedure.During analysis, the coil delivery wire was found to be kinked/bent and was returned detached from the main coil.The main coil was not returned as it was embolized at the target site during the procedure.An assignable cause of procedural factors will be assigned to the as reported (ar) / as analyzed (aa) 'main coil prematurely detached/separated during use' since this issue is 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.It is possible that the delivery wire was kinked due to additional force applied when it was used to push the prematurely detached coil from the microcatheter to the target site.An assignable cause of handling damage will be assigned to the aa 'coil delivery wire kinked/bent' since this issue is due to handling of the product during the clinical procedure.
Event or Problem Description
It was reported that a coil embolization procedure was performed in pediatrics for mapca (major aortopulmonary collateral arteries) case.During the procedure during embolization of targeted artery while advancement of the subject coil from tip of the microcatheter to the targeted site, subject coil detached prematurely in the non-stryker microcatheter and with a subject coil delivery wire the physician pushed the prematurely detached subject coil to the targeted site.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XL 360 SOFT 4MM X 12CM
• 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: 12355791
• Report Number: 3008881809-2021-00341
• Device Sequence Number: 4815588
• Product Code: HCG
• UDI-Device Identifier: 07613327128338
• UDI-Public: 07613327128338
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2021

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: 03/08/2024
• Device Model Number: M0036124120
• Device Catalogue Number: M0036124120
• Device Lot Number: 22772542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2021
• 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: LIGHTHOUSE MICROCATHETER (PIOLAX); LIGHTHOUSE MICROCATHETER (PIOLAX)
• Patient Sex: Unknown