MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 STANDARD 8MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035468300
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that during the procedure, the subject coil detached prematurely inside the micro catheter without using coil detachment system.The physician successfully completed the procedure 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 d9 product available to stryker ¿ updated d9 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 device was returned in the introducer sheath and the lot number was confirmed with the packaging returned with the device.On visual and microscope inspection, the main coil seemed to be electrolytically detached.The proximal contact wire was intact.The coil delivery wire was bent.The distal tip was found to be intact.The main coil was stretched.Functional testing 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 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 coil was not advanced or retracted with force, and the anatomy was tortuous.There was no allegation against the sl-10 microcatheter.During analysis, the coil delivery wire was found to be kinked and the main coil had been separated from the wire.The main coil was found to be stretched.Therefore, the reported event was confirmed.Although it was reported that the coil detached without the inzone in the sl-10 microcatheter, based on visual inspection, there was evidence of electrolytic detachment.In the case of this complaint, it is most likely that the main coil was only partially detached with the inzone and during withdrawal of the delivery wire in the microcatheter, the main coil stretched and premature detachment occurred.An assignable cause of procedural factors will be assigned to the as reported and as analyzed main coil prematurely detached/separated during use and as analyzed main coil stretched 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.An assignable cause of handling damage will be assigned to the as analyzed coil delivery wire kinked/bent since this issue is likely due to handling of the device during the clinical procedure.
Event or Problem Description
It was reported that during the procedure, the subject coil detached prematurely inside the micro catheter without using coil detachment system.The physician successfully completed the procedure and no clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 STANDARD 8MM X 30CM
• 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: 10667429
• Report Number: 3008881809-2020-00300
• Device Sequence Number: 17154712
• Product Code: HCG
• UDI-Device Identifier: 04546540676337
• UDI-Public: 04546540676337
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 11/19/2020

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: 01/26/2022
• Device Model Number: M0035468300
• Device Catalogue Number: M0035468300
• Device Lot Number: 21175388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 11/19/2020
• 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 MICRO CATHETER (STRYKER)