MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035423040
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that when the coil radio opaque marker (subject device) and the second marker of the microcatheter were aligned, the main coil was completely out of the microcatheter's tip.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was returned within the introducer sheath and dispenser hoop.Visual inspection of the device revealed that the ro (radio opaque) marker was confirmed to be intact.The reported misaligned ro marker could not be confirmed during analysis.The ro marker was confirmed to be in the correct position on the delivery wire of the device.The device was confirmed to be in good condition prior to use.Therefore, an assignable cause of "not confirmed" has been assigned to the reported event.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that when the coil radio opaque marker (subject device) and the second marker of the microcatheter were aligned, the main coil was completely out of the microcatheter's tip.There were no reported clinical consequences to the patient.

• Brand Name: TARGET 360 ULTRA 3MM X 4CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6330986
• Report Number: 3008881809-2017-00043
• Device Sequence Number: 16376942
• Product Code: HCG
• UDI-Device Identifier: 04546540675873
• UDI-Public: (01)04546540675873(17)181130(10)18679298
• Combination Product (Y/N): N
• PMA/510(K) Number: K093142
• 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,Followup
• Report Date (Section B): 02/19/2017

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: 11/30/2018
• Device Catalogue Number: M0035423040
• Device Lot Number: 18679298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2017
• Supplement Report FDA Received Date: 02/19/2017
• 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 MICROCATHETER (STRYKER)