MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 7MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035477200
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record (dhr) review 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.Additional information provided by the customer indicated that the coils were prepared as per device directions for use dfu and continuous flush was maintained.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned to this complaint.The subject device remained inside patient.
Event or Problem Description
It was reported that during coil embolization procedure, while deploying the 5th coil, it got stuck after a few mm inside the aneurysm.It was impossible to push it inside the aneurysm or pull it out, so the physician retrieved a little bit back and saw the fifth coil and the subject detached coil at the microcatheter¿s tip.The physician pulled the microcatheter back while pushing the coil until it got released and then pulled it back.However, the tip of the subject coil was protruded out of the aneurysm and remained outside.There was a stent that protected, and the physician stopped with coiling since he lost the microcatheter position.There were no clinical consequences to the patient due to the reported event.

• Brand Name: TARGET 360 SOFT 7MM X 20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8872294
• Report Number: 3008881809-2019-00232
• Device Sequence Number: 11522855
• Product Code: HCG
• UDI-Device Identifier: 04546540676573
• UDI-Public: 04546540676573
• 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): 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2022
• Device Catalogue Number: M0035477200
• Device Lot Number: 21338253
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention