MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035422060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.Visual & microscopic inspections revealed that the main coil was kinked/bent, stretched and broken.The coil delivery wire was also kinked, likely due to handling.Functional testing revealed that the main coil was physically detached from the delivery wire and had to be advanced/removed through the introducer sheath with a mandrel.Additional information indicated that the device was confirmed to be in good condition prior to use and the device was prepared as per the dfu.Due to some procedural/anatomical factors encountered during use, it appears that the main coil became damaged during advancement.Based on the information currently available, it appears that some procedural factors encountered during the procedure limited the performance of the coil contributing to the reported and observed damages.Therefore, an assignable cause of component failure has been assigned to this investigation.
Event or Problem Description
Analysis of the returned device noted that the coil was broken.No consequences to the patient were reported.

• Brand Name: TARGET 360 ULTRA 2MM X 6CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8634286
• Report Number: 3008881809-2019-00142
• Device Sequence Number: 2354290
• Product Code: HCG
• UDI-Device Identifier: 07613252239345
• UDI-Public: 07613252239345
• 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
• Report Date (Section B): 05/22/2019

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: 09/01/2021
• Device Catalogue Number: M0035422060
• Device Lot Number: 20838974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1