MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 24MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036182450
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2019
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 not returned.Functional testing could not be performed since the main coil was not returned.In case of this complaint, the main coil was not returned with the device; however, it could be confirmed that there was a breakage which may have been caused by the friction felt.An assignable cause of procedural factor was assigned to the as analyzed issue main coil premature detached inside patient, since the defect appears to be associated with a product that met stryker 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 1st of 2 mdr records.
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 XXL 360 24MM X 50CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8667408
• Report Number: 3008881809-2019-00155
• Device Sequence Number: 2257082
• Product Code: HCG
• UDI-Device Identifier: 07613327128376
• UDI-Public: 07613327128376
• Combination Product (Y/N): N
• PMA/510(K) Number: K161429
• 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): 06/04/2019

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: 12/31/2020
• Device Catalogue Number: M0036182450
• Device Lot Number: 20177542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 06/04/2019
• 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: EXCELSIOR 1018 MICORCATHETER (STRYKER)