MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035421530
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, the coil delivery wire was noted to be kinked/bent, and the main coil was stuck inside the introducer sheath.The main coil was also found kinked/bent, stretched and detached/separated.During functional testing, resistance was encountered when advancing the coil out of the introducer sheath confirming the initial reporter complaint.In case of this complaint, the main coil was kinked/bent, stretched and no longer attached to the pusher wire.It appears to have separated from the delivery wire, possibly when trying to advance into the catheter hub as it was stated there was difficulty inserting; therefore, procedural factor was assigned to the as analyzed issue main coil prematurely detached/separated inside patient, as these defect appear to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the direction for use (dfu), but performance was limited due to procedural or anatomical factors during use.This is 2nd of 2 reports.
Event or Problem Description
Analysis of the returned device found that the coil was prematurely detached inside patient.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: TARGET 360 NANO 1.5MM X 3CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8634203
• Report Number: 3008881809-2019-00141
• Device Sequence Number: 1748459
• Product Code: HCG
• UDI-Device Identifier: 04546540697943
• UDI-Public: 04546540697943
• 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): 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: 04/29/2021
• Device Catalogue Number: M0035421530
• Device Lot Number: 20504827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2019
• 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
• Patient Age: 70