MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 4 MM X 6 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035434060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2019
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 remained implanted; therefore, visual, dimensional and functional testing could not be performed.Based on the additional information provided by the customer, there was no damage noted to the packaging or device prior use, continuous flush was maintained, and friction was not encountered during coil advancement at any point in the procedure.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, an assignable cause of undetermined was assigned to the as reported issue of coil prematurely detachment.
Event or Problem Description
It was reported that the subject coil was used during coil embolization procedure for aneurysm located in the internal carotid artery (ica).The physician was able to introducer the coil into the patient¿s anatomy; however, the coil prematurely detached before reaching the target lesion.Two stents were implanted to secure the subject coil in place and the procedure was completed successfully.No know clinical consequences was reported to the patient due to this event.

• Brand Name: TARGET HELICAL ULTRA 4 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: 8414396
• Report Number: 3008881809-2019-00070
• Device Sequence Number: 420433
• Product Code: HCG
• UDI-Device Identifier: 04546540676108
• UDI-Public: 04546540676108
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 03/12/2019

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: 11/05/2021
• Device Catalogue Number: M0035434060
• Device Lot Number: 20975004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 03/12/2019
• 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 MICROCATHETER SL-10 (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 65