MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035476200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During visual inspection, the delivery wire was found kinked/bent at the main junction area and the main coil was broken/fractured at the main coil junction area.During functional testing, the main coil was physically detached from the delivery wire.Additional information provided by the customer confirmed that the device was prepared as per device direction for use (dfu) and was in a good condition prior to the procedure.Based on the available information and device analysis, it is probable that procedural factors encountered during the procedure contributed to the reported ¿nv ¿ coil in catheter friction¿ and to the analyzed ¿nv ¿ coil delivery wire kinked/bent¿ and ¿nv - main coil broken/fractured¿.Therefore, as assignable cause of procedural factor was assigned to this investigation.
Event or Problem Description
Analysis of the returned device found that the subject coil was broken/fractured.There were no clinical consequences to the patient reported.

• Brand Name: TARGET 360 SOFT 6MM X 20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7636868
• Report Number: 3008881809-2018-00280
• Device Sequence Number: 2435744
• Product Code: HCG
• UDI-Device Identifier: 04546540676542
• UDI-Public: 04546540676542
• Combination Product (Y/N): N
• 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): 06/26/2018

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: 12/31/2018
• Device Catalogue Number: M0035476200
• Device Lot Number: 18755227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/26/2018
• 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: MICROCATHETER (UNKNOWN)