MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 3 MM X 4 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035443040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
During the coil embolization procedure, it was reported that the coil got stuck in the microcatheter and broke.No clinical consequences reported to the patient.No further information is available now.
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 main coil was stretched, and broken inside the patient.In addition, the coil delivery wire was kinked due to handling damage.The functional test was unable to be performed due to the condition of the returned device.As per the additional information, the coil was confirmed to be in good condition prior to use and was prepared as per the dfu (direction for use).It is probable that the main coil was jammed within the microcatheter and it was stretched and broken/ fractured during removal from the patient.An assignable cause of cause traced to component failure will be assigned to the reported event and the analyzed defects 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 but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
During the coil embolization procedure, it was reported that the coil got stuck in the microcatheter and broke.No clinical consequences reported to the patient.No further information is available now.

• Brand Name: TARGET 360 NANO 3 MM X 4 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8200439
• Report Number: 3008881809-2018-00546
• Device Sequence Number: 16548391
• Product Code: HCG
• UDI-Device Identifier: 07613252600336
• UDI-Public: 07613252600336
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/27/2019

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: 04/30/2020
• Device Catalogue Number: M0035443040
• Device Lot Number: 19710789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1