MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036121040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2020
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 procedure the physician tried to insert the subject coil into the microcatheter and the subject coil prematurely detached while it was inside the patient.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added d4 expiration date - added 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 no anomalies noted to the device prior to use and device prepared as per the dfu.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned for analysis, a cause of undeterminable will be assigned to the reported complaint.
Event or Problem Description
It was reported that during the procedure the physician tried to insert the subject coil into the microcatheter and the subject coil prematurely detached while it was inside the patient.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET XL 360 SOFT 10MM X 40CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 10237411
• Report Number: 3008881809-2020-00195
• Device Sequence Number: 3093094
• Product Code: HCG
• UDI-Device Identifier: 07613327004601
• UDI-Public: 07613327004601
• Combination Product (Y/N): N
• 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): 09/02/2020

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: 01/05/2022
• Device Model Number: M0036121040
• Device Catalogue Number: M0036121040
• Device Lot Number: 21121134
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 09/02/2020
• 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: BREAKTHROUGH MICRO CATHETER (BOSTON SCIENTIFIC)