MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 2MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035432080
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Additional information provided by the customer indicated that intermittent flush was maintained.It is probable that insufficient flush contributed to the event.As per the device direction for use (dfu), ¿in order to achieve optimal performance of the target detachable coil system and to reduce the risk of thromboembolic complications, it is critical that a continuous infusion of appropriate flush solution be maintained between a) the femoral sheath and guiding catheter, b) the 2-tip microcatheter and guiding catheters, and c) the 2-tip microcatheter and stryker neurovascular guidewire and delivery wire.Continuous flush also reduces the potential for thrombus formation on, and crystallization of infusate around, the detachment zone of the target detachable coil.¿ based on the investigation results and available information an assignable cause of user error will be assigned to this complaint.Issue investigation confirmed that there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer and/or expected by the user.The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that when the subject coil was attempted to insert for bronchial artery embolization, the resistance was encountered from the middle of the microcatheter and the subject coil was prematurely detached in the target artery.The tail part of the subject coil was remained inside the microcatheter; therefore; a flush with saline was given to push the remaining subject coil into the target artery and the tail of the subject coil was successfully placed inside target artery.The procedure was continued and completed without any problems.There were no clinical consequences to the patient due to the reported event.

• Brand Name: TARGET HELICAL ULTRA 2MM 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: 9269234
• Report Number: 3008881809-2019-00330
• Device Sequence Number: 2498652
• Product Code: HCG
• UDI-Device Identifier: 04546540676023
• UDI-Public: 04546540676023
• 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): 11/01/2019

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: 03/23/2022
• Device Catalogue Number: M0035432080
• Device Lot Number: 21311313
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR