MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 7MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035477300
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 2 of the 2 reports for this event.The subject device is not available.
Event or Problem Description
During the coil embolization procedure, it was reported that difficulty was encountered when the delivery wire of the second coil was inserted into the detachment system and the proximal contact was bent.Then the physician tried to detach the coil, however even though long beep was sounded twice the coil could not be detached.So the physician removed the delivery wire from the detachment system and reinserted again, but the detachment system did not power on.Therefore, the physician decided to remove the coil.After removal the proximal part of the delivery wire from the detachment system, the physician confirmed that the anode of the proximal contact was exposed.In addition, when the physician tried to remove the second coil from the patient, it was found that the second coil was tangled with the first coil (subject device) which was initially successfully implanted in the aneurysm.Hence both coils were retrieved with snare.The procedure was completed with other coils.No clinical consequences reported to the patient.
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 after unpacking and the device was prepared as per the dfu (direction for use).Based on the information currently available the exact cause for the reported event cannot be determined.
Event or Problem Description
During the coil embolization procedure, it was reported that difficulty was encountered when the delivery wire of the second coil was inserted into the detachment system and the proximal contact was bent.Then the physician tried to detach the coil, however even though long beep was sounded twice the coil could not be detached.So the physician removed the delivery wire from the detachment system and reinserted again, but the detachment system did not power on.Therefore, the physician decided to remove the coil.After removal the proximal part of the delivery wire from the detachment system, the physician confirmed that the anode of the proximal contact was exposed.In addition, when the physician tried to remove the second coil from the patient, it was found that the second coil was tangled with the first coil (subject device) which was initially successfully implanted in the aneurysm.Hence both coils were retrieved with snare.The procedure was completed with other coils.No clinical consequences reported to the patient.

• Brand Name: TARGET 360 SOFT 7MM X 30CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7467317
• Report Number: 3008881809-2018-00189
• Device Sequence Number: 13693768
• Product Code: HCG
• UDI-Device Identifier: 04546540676580
• UDI-Public: (01)04546540676580(17)190930(10)19345369
• Combination Product (Y/N): N
• PMA/510(K) Number: K153658
• 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): 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: M0035477300
• Device Catalogue Number: M0035477300
• Device Lot Number: 19345369
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 04/26/2018
• Supplement Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention