MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2.5MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035422540
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available to the manufacturer.
Event or Problem Description
It was reported that while deploying the subject coil, the coil didn't go completely into the lumen of aneurysm and the tip of microcatheter went out of the aneurysm.The physician withdrew the subject coil slowly and found the tip of coil was prematurely detached inside the microcatheter.The physician replaced the coil and completed the procedure successfully.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the main coil manually detached and not returned.The coil delivery wire was severely kinked/bent; likely due to handling damage.It can be presumed that the delivery wire was damage during the procedure as force may have been applied when the friction was felt.Functional testing was not performed since the main coil 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.Additional information provided by the customer 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.During investigation, the main coil was not returned and was detached from the delivery wire.Analysis of the detachment zone of the guidewire showed evidence of mechanical detachment.In case of this complaint, it is most likely that the coil was manipulated against friction in the microcatheter and upon attempted withdrawal, the coil detached from the delivery wire.A probable cause of procedural factors will be assigned to the as reported and as analyzed issue, 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 while deploying the subject coil, the coil didn't go completely into the lumen of aneurysm and the tip of micorcatheter went out of the aneurysm.The physician withdrew the subject coil slowly and found the tip of coil was prematurely detached inside the microcatheter.The physician replaced the coil and completed the procedure successfully.There were no reported clinical consequences to the patient.

• Brand Name: TARGET 360 ULTRA 2.5MM X 4CM
• 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: 10037030
• Report Number: 3008881809-2020-00141
• Device Sequence Number: 14232099
• Product Code: HCG
• UDI-Device Identifier: 04546540675866
• UDI-Public: 04546540675866
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 07/02/2020

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: 03/09/2022
• Device Model Number: M0035422540
• Device Catalogue Number: M0035422540
• Device Lot Number: 21292204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 06/14/2020
• Initial Report FDA Received Date: 05/07/2020
• Supplement Report FDA Received Date: 07/03/2020
• 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)
• Patient Age: 65 YR