MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036125150
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device not returned.
Event or Problem Description
It was reported that the subject coil was prematurely detached inside the microcatheter shaft without using the detachment system; therefore, the physician had to use a snare device to remove the coil from the patient anatomy and the procedure was completed successfully.No clinical consequences were reported 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 and functional testing could not be performed since the device 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 the subject target coil was prematurely detached inside the microcatheter and a snare device was used to remove the coil from the patient's anatomy.Additional information provided by the customer indicated that continuous flush was not set up and maintained throughout the clinical procedure.Per the dfu, continuous flush is critical to prevent friction related issues in the microcatheter and to achieve optimal performance of the target coil.In the case of this complaint, it is probable that failure to administer continuous flush contributed to difficulty advancing the coil in the microcatheter and as a result, the coil prematurely detached.An assignable cause of use error will be assigned to this complaint since there was a deviation from the supplied dfu that resulted in a different medical product response than intended by the manufacturer or expected by the user.
Event or Problem Description
It was reported that the subject coil was prematurely detached inside the microcatheter shaft without using the detachment system; therefore, the physician had to use a snare device to remove the coil from the patient anatomy and the procedure was completed successfully.No clinical consequences were reported due to this event.

• Brand Name: TARGET XL 360 SOFT 5MM X 15CM
• 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: 11228247
• Report Number: 3008881809-2021-00048
• Device Sequence Number: 3513008
• Product Code: HCG
• UDI-Device Identifier: 07613327128291
• UDI-Public: 07613327128291
• 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): 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2023
• Device Model Number: M0036125150
• Device Catalogue Number: M0036125150
• Device Lot Number: 22182632
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 03/30/2021
• 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: SNARE DEVICE (UNKNOWN MANUFACTURER); SNARE DEVICE (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Required Intervention