MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035424150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is unavailable.
Event or Problem Description
It was reported that prior the subject coil embolization procedure of the middle cerebral artery (mca), it was found that the distal of position which was near the shaft proximal was fractured.The fractured parts were still connected at that time.So, the operator replaced the subject coil with another one in same type to complete the procedure.There was no reported clinical consequence to the patient.
Event or Problem Description
It was reported that prior the subject coil embolization procedure of the middle cerebral artery (mca), it was found that the distal of position which was near the shaft proximal was fractured.The fractured parts were still connected at that time.So, the operator replaced the subject coil with another one in same type to complete the procedure.There was no reported clinical consequence to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Inspection of the returned device found the delivery wire was broken near the proximal contact outside patient.A functional test could not be performed due to the observed anomalies.In the case of this complaint it was reported: 'opened the package of the coil and the condition of package was good.Took the loop out and its condition was good as well.Then flushed normally and took the coil together with shaft, however the operator found that the distal of position which was near the shaft proximal was fractured.Therefore; an assignable cause of ¿not confirmed¿ will be assigned to the 'main coil broken outside patient¿ as this defect was not confirmed.Based on the investigation results and available information, an assignable cause of handling damage to the ¿coil delivery wire broken/fractured outside patient' as it is most likely that the delivery wire broke due to handling of the device during prep.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: TARGET 360 ULTRA 4MM X 15CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8270828
• Report Number: 3008881809-2019-00033
• Device Sequence Number: 1448695
• Product Code: HCG
• UDI-Device Identifier: 04546540675941
• UDI-Public: 04546540675941
• 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): 03/20/2019

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: 05/08/2021
• Device Catalogue Number: M0035424150
• Device Lot Number: 20519411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR