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

Catalog Number	M0036182450
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2018
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.The subject device was not returned, therefore physical and functional tests could not be performed.In the case of this complaint it is most likely that the main coil that the main coil broke during insertion due to lack of continuous flush maintained during the procedure, as per device direction for use (dfu) maintaining continuous flush throughout the procedure is a critical requirement as lack of it can result in difficulty during procedure.Also, as reported that a non-stryker microcatheter was used for performing the procedure it can also contribute to failure due to potential incompatibility of non-stryker device, leading to main coil broken.As per additional information device was prepared as per (dfu) for this product.However, contrary to this - the additional information states that continuous flush was not maintained during the procedure, which is against the dfu for this product.Therefore; an assignable cause of ¿user error¿ will be assigned to reported event, as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer and/or expected by the user.This is 1 of 2 reports.The subject device in unavailable.
Event or Problem Description
It was reported that the subject device coil was broken during insertion.Another device was used to complete the procedure.There were no clinical consequences to the patient due to the reported 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: 7975993
• Report Number: 3008881809-2018-00445
• Device Sequence Number: 13873480
• 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): 10/17/2018

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: 03/04/2021
• Device Catalogue Number: M0036182450
• Device Lot Number: 20356568
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1