MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036181040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during coil embolization of a hepatic aneurysm after inserting 25 coils (non-stryker devices), the subject coil was inserted into the non-stryker microcatheter and the coil prematurely detached.The subject coil and the microcatheter were removed.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
Expiration date: updated, manufacturing date: updated.The device history record 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.Information available indicated that the device was confirmed to be in good condition prior to use.Based on the information currently available, the exact cause for the reported event cannot be determined.
Event or Problem Description
It was reported that during coil embolization of a hepatic aneurysm after inserting 25 coils (non-stryker devices), the subject coil was inserted into the non-stryker microcatheter and the coil prematurely detached.The subject coil and the microcatheter were removed.There were no clinical consequences to the patient.

• Brand Name: TARGET XXL 360 10MM X 40CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8621864
• Report Number: 3008881809-2019-00133
• Device Sequence Number: 380865
• Product Code: HCG
• UDI-Device Identifier: 07613327128406
• UDI-Public: 07613327128406
• 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): 06/12/2019

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: Health Professional
• Device Expiration Date: 12/02/2021
• Device Catalogue Number: M0036181040
• Device Lot Number: 21053001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 06/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1