MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 12MM X 45CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036121240
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported the coil prematurely detached and the physician had to use a lasso snare to retrieve the coil from the patient.No additional information is available.
Additional Manufacturer Narrative
Product available to stryker - device received, updated to 'return'.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Inspection of the returned device found the delivery wire was kinked, likely due to handling, and the main coil was prematurely detached.Additional information stated the main coil detached before it could be retracted into the microcatheter, indicating the coil was being repositioned.Based on device analysis and information available, it is probable the device was damaged during the procedure, possibly due to excessive force, and the coil detached due to a physical break at the main coil junction.As such, ¿cause traced to component failure' was assigned to this investigation.
Event or Problem Description
It was reported the coil prematurely detached and the physician had to use a lasso snare to retrieve the coil from the patient.No additional information is available.

• Brand Name: TARGET XL 360 SOFT 12MM X 45CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7473537
• Report Number: 3008881809-2018-00195
• Device Sequence Number: 16171367
• Product Code: HCG
• UDI-Device Identifier: 04546540711533
• UDI-Public: (01)04546540711533(17)210131(10)20227774
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 07/10/2018

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: 01/31/2021
• Device Model Number: M0036121240
• Device Catalogue Number: M0036121240
• Device Lot Number: 20227774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 07/10/2018
• 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: LASSO SNARE (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Required Intervention