MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 4MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035474080
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, the target coil was returned within the microcatheter.The delivery wire and the main coil were noted to be kinked/bent and the main coil was found detached inside the microcatheter.Functional testing could not be performed due to the anomalies noted to the device.In case of this complaint, it is most likely that the coil kinked during coil advancement against friction.The coil then detached most likely during removal of the coil from the catheter; however, this cannot be conclusively determined.This complaint appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the direction for use (dfu), but performance was limited due to procedural factors during use.Therefore, an assignable cause of procedural factors was assigned to the as analyzed issue main coil prematurely detached/separated inside patient.
Event or Problem Description
Analysis of the returned device found that the coil prematurely detached/separated inside the patient.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: TARGET 360 SOFT 4MM X 8CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8906612
• Report Number: 3008881809-2019-00245
• Device Sequence Number: 14043834
• Product Code: HCG
• UDI-Device Identifier: 04546540676467
• UDI-Public: 04546540676467
• 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): 08/19/2019

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: 09/01/2021
• Device Catalogue Number: M0035474080
• Device Lot Number: 20842431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 08/19/2019
• 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 XT-17 MICROCATHETER (STRYKER)
• Patient Age: 80