MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035422040
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
During the coil embolization, the physician experienced resistance while advancing the 4th coil so he pulled back the coil delivery wire but the 4th coil had stuck and tangled with the 3rd coil (subject coil).The physician suspect that the 3rd coil may have been detached and remained in the microcatheter.It was reported that the detached coil was removed along with the 4th coil without clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Analysis of the device confirmed that the coil was detached from the delivery wire and the coil was found to be kinked.Functional testing was not performed due to the damage noted to the returned device.Information available indicated that the device was confirmed to be in good condition prior to use.It is most likely that anatomical factors encountered during the procedure contributed to the reported detachment of the coil resulting in the reported and observed defects.Therefore, an assignable cause of operational context was assigned to this investigation.
Event or Problem Description
During the coil embolization, the physician experienced resistance while advancing the 4th coil so he pulled back the coil delivery wire but the 4th coil had stuck and tangled with the 3rd coil (subject coil).The physician suspect that the 3rd coil may have been detached and remained in the microcatheter.It was reported that the detached coil was removed along with the 4th coil without clinical consequences to the patient.

• Brand Name: TARGET 360 ULTRA 2MM 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: 6490653
• Report Number: 3008881809-2017-00111
• Device Sequence Number: 556043
• Product Code: HCG
• UDI-Device Identifier: 04546540675842
• UDI-Public: (01)04546540675842(17)181031(10)18629751
• Combination Product (Y/N): N
• Initial Reporter Country: SG
• PMA/510(K) Number: K102672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2017

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: 10/31/2018
• Device Model Number: M0035422040
• Device Catalogue Number: M0035422040
• Device Lot Number: 18629751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Initial Date Received by Manufacturer: 03/16/2017
• Supplement Date Received by Manufacturer: 06/27/2017
• Initial Report FDA Received Date: 04/13/2017
• Supplement Report FDA Received Date: 07/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR