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

Catalog Number	M0036181240
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during coil embolization procedure while trying to place the third coil (subject device), early detachment occurred while inserting and pulling back.The coil was collected within the microcatheter.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual examination of the returned device revealed that the main coil was seen to have detached from the delivery wire at the main coil junction.Functional testing was not carried out due to the condition of the coil retuned.Based on this and on additional information received, the reported "main coil prematurely detached/separated inside the patient' was confirmed.Therefore, an assignable cause of procedural factors has been assigned to this investigation.
Event or Problem Description
It was reported that during coil embolization procedure while trying to place the third coil (subject device), early detachment occurred while inserting and pulling back.The coil was collected within the microcatheter.There were no clinical consequences to the patient.

• Brand Name: TARGET XXL 360 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: 8171679
• Report Number: 3008881809-2018-00532
• Device Sequence Number: 19197488
• Product Code: HCG
• UDI-Device Identifier: 07613327128307
• UDI-Public: 07613327128307
• Combination Product (Y/N): N
• PMA/510(K) Number: K161429
• 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): 02/08/2019

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: No Information
• Device Expiration Date: 07/21/2021
• Device Catalogue Number: M0036181240
• Device Lot Number: 20743240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1