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

Catalog Number	M0035478300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
During the stent assisting coil embolization procedure for an aneurysm, it was reported that big resistance was encountered when advancing the 9th coil in the microcatheter.So the physician withdraw the coil and found it was stretched and fractured.Then the whole coil was removed from the patient and the procedure was completed successfully after changing to another coil.The patient¿s condition was reported to be good.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed that the delivery wire was kinked due to handling damage and the main coil was prematurely detached inside the patient.In addition, the delivery wire detachment zone was inspected, and the main coil appears to have detached due to a physical break.The functioning test could not be performed due to the condition of the returned device.Additional information indicates that no anomalies were noted to the device prior to use and there is no indication of a use error.The device is likely to have been damaged during use resulting in the reported events.An assignable cause of cause traced to component failure will be assigned to the as reported event and to the as analyzed defect on the main coil.As the issue is associated with a product that meets the design and manufacture specifications and was used in according with the dfu (direction for use) but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
During the stent assisting coil embolization procedure for an aneurysm, it was reported that big resistance was encountered when advancing the 9th coil in the microcatheter.So the physician withdraw the coil and found it was stretched and fractured.Then the whole coil was removed from the patient and the procedure was completed successfully after changing to another coil.The patient¿s condition was reported to be good.

• Brand Name: TARGET 360 SOFT 8MM X 30CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8205262
• Report Number: 3008881809-2018-00556
• Device Sequence Number: 1652914
• Product Code: HCG
• UDI-Device Identifier: 04546540676603
• UDI-Public: 04546540676603
• 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): 02/25/2019

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: 06/18/2021
• Device Catalogue Number: M0035478300
• Device Lot Number: 20622992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 12/29/2018
• Supplement Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 75