MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035424060
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available.
Event or Problem Description
During a coil embolization procedure, detachment of the coil was performed; however, the coil did not detach.It was reported that during withdrawal of the coil, it detached, and a snare device was used to remove the coil.The procedure was continued with another coil without clinical consequences to the patient.
Additional Manufacturer Narrative
Manufacturer and expiration date: updated the device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.Review and analysis of all available information failed to indicate an assignable cause or probable assignable cause for the reported event.Based on the information available the exact cause for the reported event cannot be determined.
Event or Problem Description
During a coil embolization procedure, detachment of the coil was performed; however, the coil did not detach.It was reported that during withdrawal of the coil, it detached, and a snare device was used to remove the coil.The procedure was continued with another coil without clinical consequences to the patient.

• Brand Name: TARGET 360 ULTRA 4MM 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: 6730367
• Report Number: 3008881809-2017-00217
• Device Sequence Number: 762281
• Product Code: HCG
• UDI-Device Identifier: 04546540675910
• UDI-Public: (01)04546540675910(17)190430(10)18972366
• Combination Product (Y/N): N
• 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): 09/07/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: M0035424060
• Device Catalogue Number: M0035424060
• Device Lot Number: 18972366
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 08/10/2017
• Initial Report FDA Received Date: 07/20/2017
• Supplement Report FDA Received Date: 09/07/2017
• 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
• Patient Age: 68 YR