MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 3.5MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035443560
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2020
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 subject coil broke off while the physician was retracting it into the micro catheter.The broken coil was retrieved using a guide wire through the micro catheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was received.The reported lot number was not confirmed as the packaging was not returned with the device.On visual inspection, the main coil was seen to be emerging from the catheter.The main coil was removed and was seen to be detached from pusher wire.The main coil was also seen to be kinked bent.Functional testing was not required.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 main coil was seen to be detached from the pusher wire.It may have been interpreted as being broken/fractured by the physician and therefore the as reported can be confirmed.The as reported main coil broken/fractured during use as well as the as analyzed main coil prematurely detached/separated during use and main coil kinked/bent can be assigned procedural factors as this complaint appears 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 factors during use.
Event or Problem Description
It was reported that during the procedure the subject coil broke off while the physician was retracting it into the micro catheter.The broken coil was retrieved using a guide wire through the micro catheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 NANO 3.5MM X 6CM
• 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: 11135616
• Report Number: 3008881809-2021-00016
• Device Sequence Number: 2350106
• Product Code: HCG
• UDI-Device Identifier: 07613252600343
• UDI-Public: 07613252600343
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 03/17/2021

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: 08/04/2023
• Device Model Number: M0035443560
• Device Catalogue Number: M0035443560
• Device Lot Number: 22362812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 03/17/2021
• 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: BENCHMARK GUIDE CATHETER (PENUMBRA); SL-10 MICRO CATHETER (STRYKER); SYNCHRO GUIDE WIRE (STRYKER)
• Patient Age: 63 YR