MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 3 MM X 6 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035443060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during a cerebral aneurysm procedure, the subject coil prematurely detached in the microcatheter when pulled.The microcatheter and subject coil were removed together and replaced with other units.The procedure was completed without any problems and there were no clinical consequences to the patient due to the reported event.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During the analysis of the returned device, it was revealed that the main coil was stretched and prematurely detached inside the patient and the main coil suture was damaged.In addition, the coil delivery wire was kinked due to handling.It is most likely that anatomical or procedural factors resulted in the coil becoming stuck in the concurrent micro catheter and eventually physically detaching within the microcatheter due to manipulation of the device.The event appears to be associated with a product that met the design and manufacturing specifications and was used in accordance with the dfu (direction for use), but performance was limited due to procedural or anatomical factors during use.Therefore, a cause of procedural factors will be assigned to the damage to the reported and analyzed issue for the main coil.
Event or Problem Description
It was reported that during a cerebral aneurysm procedure, the subject coil prematurely detached in the microcatheter when pulled.The microcatheter and subject coil were removed together and replaced with other units.The procedure was completed without any problems and there were no clinical consequences to the patient due to the reported event.

• Brand Name: TARGET 360 NANO 3 MM X 6 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8729607
• Report Number: 3008881809-2019-00180
• Device Sequence Number: 11244094
• Product Code: HCG
• UDI-Device Identifier: 07613252600329
• UDI-Public: 07613252600329
• Combination Product (Y/N): N
• 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): 08/14/2019

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: 12/17/2021
• Device Catalogue Number: M0035443060
• Device Lot Number: 21101130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2019
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 08/14/2019
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER); FUBUKI GUIDE CATHETER (NON-STRYKER); TRANSEND EX PLUTINUM GUIDEWIRE (STRYKER)