MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 3 MM X 10 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035433100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	12/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that during the coil embolization procedure, the coil was once inserted and recoiling several times, but coil was not placed in the right position.So, it was removed and attempted to reinsert but there was a resistance.Once the coil was removed and checked, there was thrombus adhered.The product was exchanged with the same product and procedure completed without problems.No clinical consequences were reported to the patient due to the event.
Additional Manufacturer Narrative
Expiration date: added.Manufacturing date: added.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.The case of this complaint it is possible that the main coil encountered friction while advancing through microcatheter due to intermittent flush maintained during the procedure, as reported that thrombus was present on the detachment zone of coil which can happen as a result to lack of continuous flush, leading to the as reported events of friction and thrombosis.Based on the investigation results and available information an assignable cause of anticipated procedural complication will be assigned to the patient thrombosis.As per additional information no damage was noted to the device prior to use and the device was prepared as per dfu for this product.However, contrary to this - the additional information states that continuous flush was not maintained during the procedure which is against the dfu for this product.
Event or Problem Description
It was reported that during the coil embolization procedure, the coil was once inserted and recoiling several times, but coil was not placed in the right position.So, it was removed and attempted to reinsert but there was a resistance.Once the coil was removed and checked, there was thrombus adhered.The product was exchanged with the same product and procedure completed without problems.No clinical consequences were reported to the patient due to the event.

• Brand Name: TARGET HELICAL ULTRA 3 MM X 10 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8241413
• Report Number: 3008881809-2019-00021
• Device Sequence Number: 2190253
• Product Code: HCG
• UDI-Device Identifier: 04546540676092
• UDI-Public: 04546540676092
• 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): 01/30/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/27/2021
• Device Catalogue Number: M0035433100
• Device Lot Number: 20576921
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 01/30/2019
• 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: Other