MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 18MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036181850
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.Information available indicated that coil was confirmed to be in good condition prior to use, the device was prepared per the dfu and continuous flush was maintained.It was also reported that the renegade hf micro catheter ( inner diameter 0.027¿) was used to advance the subject device to the delivery site.Per the device dfu: ¿a maximum inner diameter of 0.019 is compatible with the target coils.¿ based on the information available, an assignable cause of use error was assigned to this event.The device is not available to the manufacturer.
Event or Problem Description
It was reported that when the coil(subject device) was advanced in the microcatheter, the coil detached prematurely inside the micro catheter.The coil was retrieved along with the microcatheter.There were no reported clinical consequences to the patient.

• Brand Name: TARGET XXL 360 18MM 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: 8471750
• Report Number: 3008881809-2019-00086
• Device Sequence Number: 16624724
• Product Code: HCG
• UDI-Device Identifier: 07613327128413
• UDI-Public: 07613327128413
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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): 04/01/2019

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: 08/18/2021
• Device Catalogue Number: M0036181850
• Device Lot Number: 20794983
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 04/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1