MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 20MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036102050
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/26/2019
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 coil (subject device) used was released within the microcatheter prior to being implanted.The procedure was completed successfully and no clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added h3 device evaluated by mfg ¿updated h3 summary attached - updated d4 expiration date - added d10 product available to stryker ¿ updated d10 returned to manufacturer on ¿updated due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The coil delivery wire was not returned while the main coil was returned detached.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.The reported defect was confirmed.The device failed to meet specifications when returned for analysis.It is probable that the device was damaged during advancement through the patients anatomy causing the reported event.An assignable cause of procedural factors will be assigned to the reported ¿main coil prematurely detached/separated during use¿ and as analysed ¿nv- main coil kinked/bent' as the issue is associated with a product that meets stryker design manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural or anatomical factors during use.
Event or Problem Description
It was reported that during the procedure the coil (subject device) used was released within the microcatheter prior to being implanted.The procedure was completed successfully and no clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XL 360 STANDARD 20MM X 50CM
• 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: 9674708
• Report Number: 3008881809-2020-00035
• Device Sequence Number: 14149154
• Product Code: HCG
• UDI-Device Identifier: 07613327004731
• UDI-Public: 07613327004731
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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): 04/04/2020

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: 07/25/2021
• Device Model Number: M0036102050
• Device Catalogue Number: M0036102050
• Device Lot Number: 20738335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 04/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 80