MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 18MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036121850
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available to the manufacturer yet.
Event or Problem Description
It was reported that during the procedure, the subject coil prematurely detached while being advanced inside the micro catheter.The physician replaced the coil and completed the procedure successfully.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
D4 expiration date - added.D10 product available to stryker - updated.H3 device evaluated by mfg - updated.H3 summary attached - updated.H4 manufacturing date ¿ added.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned and the lot number was confirmed with the packaging returned with the device.Visual analysis revealed that the coil was manually detached, the coil delivery wire was kinked/bent and the main coil was stretched.Functional analysis was not required as the reported defect was confirmed during analysis.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 indicated that no anomalies were noted to the device during preparation/prior to use, continuous flush was maintained, and the same microcatheter (sl-10) was successfully used to complete the procedure after the reported event.Analysis of the detachment zone showed evidence of mechanical detachment.In this complaint, it is most likely that the coil was manipulated against friction in the microcatheter and upon attempted withdrawal, the coil stretched and then detached from the delivery wire.A probable cause of "procedural factors" will be assigned to this event since these issues appear to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.
Event or Problem Description
It was reported that during the procedure, the subject coil prematurely detached while being advanced inside the micro catheter.The physician replaced the coil and completed the procedure successfully.There were no reported clinical consequences to the patient.

• Brand Name: TARGET XL 360 SOFT 18MM 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: 9617960
• Report Number: 3008881809-2020-00013
• Device Sequence Number: 523935
• Product Code: HCG
• UDI-Device Identifier: 04546540711564
• UDI-Public: 04546540711564
• 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): 03/23/2020

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: 10/24/2021
• Device Model Number: M0036121850
• Device Catalogue Number: M0036121850
• Device Lot Number: 20986600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 03/23/2020
• 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: EXCELSIOR SL-10 MICROCATHETER(STRYKER)