MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 8MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035478300
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The edhr (electronic device history record) for the device lot is created and maintained in mes (manufacturing execution system).Automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned inserted in the introducer sheath and the dispenser hoop.Analysis of the returned device revealed the delivery wire was kinked due to handling of the device during use.Additionally, the main coil was found to be stretched and detached from the delivery wire.The main coil was noted to be stuck in the hub and catheter shaft of the concurrent micro catheter.It is most probable that procedural or anatomical factors encountered during the insertion of the 30cm target coil into the microcatheter contributed to the reported event.The device was analysed and the 30cm main coil was inserted in the microcatheter and the detachment area of the main coil was noted to be physically detached within the hub of the microcatheter, indicating force may have been used during the insertion process.Based on the analysis results and available information, an assignable cause of procedural factors will be assigned to this investigation as the issue is associated with a product that meets stryker design and manufacture specifications and was used according to the device directions for use (dfu) but due to procedural and/or anatomical factors during use, the device performance was limited.
Event or Problem Description
Analysis of the device revealed that the subject coil prematurely detached inside patient.There was no clinical consequence to the patient as a result of this event.

• Brand Name: TARGET 360 SOFT 8MM X 30CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8684354
• Report Number: 3008881809-2019-00163
• Device Sequence Number: 11321012
• Product Code: HCG
• UDI-Device Identifier: 04546540676603
• UDI-Public: 04546540676603
• 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
• Report Date (Section B): 06/10/2019

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: 12/31/2019
• Device Catalogue Number: M0035478300
• Device Lot Number: 19499018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 06/10/2019
• 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: SL-10 MICROCATHETER (STRYKER)