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	06/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the coil embolization procedure, a coil (subject device) was inserted inside the patient¿s anatomy in combination with a microcatheter.The subject coil encountered resistance inside the microcatheter during advancement.When the physician continued to deliver the subject coil, it prematurely detached without detachment attempt inside the microcatheter.The subject coil was remained inside the microcatheter and was removed along with the removal of the microcatheter from the patient¿s anatomy.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
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 complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product 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.It was reported that there was resistance inside excelsior xt-17.The coil continued to deliver but it prematurely detached inside excelsior xt-17 (detached unintentionally without using inzone).Both target and excelsior xt-17 was discontinued to use.The products were exchanged with same lot one and the procedure completed without problem.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, the rhv was opened enough to allow passage of the device through without damage, no excessive force was applied while advancing the coil, and no torque was given where advancing the delivery wire.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.
Event or Problem Description
It was reported that during the coil embolization procedure, a coil (subject device) was inserted inside the patient¿s anatomy in combination with a microcatheter.The subject coil encountered resistance inside the microcatheter during advancement.When the physician continued to deliver the subject coil, it prematurely detached without detachment attempt inside the microcatheter.The subject coil was remained inside the microcatheter and was removed along with the removal of the microcatheter from the patient¿s anatomy.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• 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: 12167229
• Report Number: 3008881809-2021-00298
• Device Sequence Number: 4259200
• 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,Followup
• Report Date (Section B): 09/02/2021

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: 03/15/2023
• Device Model Number: M0036127200
• Device Catalogue Number: M0036127200
• Device Lot Number: 22192714
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR XT-17 MICROCATHETER (STRYKER); INZONE POWER SUPPLY (STRYKER); EXCELSIOR XT-17 MICROCATHETER (STRYKER); INZONE POWER SUPPLY (STRYKER)