MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035423060
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device disposed of at the hospital.
Event or Problem Description
During procedure the physician was trying to detach a coil, pressed inzone, and received a long beep, then pressed the inzone again and after receiving the 3 beeps presumed that the coil detached.Physician pulled back the microcatheter to check under the fluoroscopy if the coil detached, but the microcatheter popped out of the aneurysm, coil was pulled into the microcatheter and prematurely detached.The coil and delivery wire were successfully removed from the patient and there was no clinical consequence noted to the patient due to the reported event.
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 as well as a functional evaluation could not be performed.Information available indicated that the device was confirmed to be in good condition prior to use.Based on the information currently available the exact cause for the reported issue cannot be determined.
Event or Problem Description
During procedure the physician was trying to detach a coil, pressed inzone, and received a long beep, then pressed the inzone again and after receiving the 3 beeps presumed that the coil detached.Physician pulled back the microcatheter to check under the fluoroscopy if the coil detached, but the microcatheter popped out of the aneurysm, coil was pulled into the microcatheter and prematurely detached.The coil and delivery wire were successfully removed from the patient and there was no clinical consequence noted to the patient due to the reported event.

• Brand Name: TARGET 360 ULTRA 3MM X 6CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 5923103
• Report Number: 3008881809-2016-00157
• Device Sequence Number: 10880624
• Product Code: HCG
• UDI-Device Identifier: 04546540675880
• UDI-Public: (01)04546540675880(17)190131(10)18819189
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102672
• 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): 08/07/2016

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: 01/31/2018
• Device Catalogue Number: M0035423060
• Device Lot Number: 18819189
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2016
• Supplement Report FDA Received Date: 12/13/2016
• 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: ECHELON 10 MICROCATHETER