MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 7MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036127200
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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, no excessive force was applied while advancing the coil, friction was felt at the middle part of the catheter, the coil was advanced slowly and gently, and the coil was detached at the detachment zone inside the micro catheter.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the embolization the subject coil was inserted into the micro catheter.While advancing the subject coil at the middle of the micro catheter resistance was felt.When the physician pulled the delivery wire of the subject coil it prematurely detached inside the micro catheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XL 360 SOFT 7MM X 20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11610317
• Report Number: 3008881809-2021-00151
• Device Sequence Number: 19656159
• Product Code: HCG
• UDI-Device Identifier: 07613327004632
• UDI-Public: 07613327004632
• 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
• Report Date (Section B): 04/02/2021

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: 08/17/2023
• Device Model Number: M0036127200
• Device Catalogue Number: M0036127200
• Device Lot Number: 22393612
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1