MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0035421520

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2017

Event Type  malfunction  

Event Description

It was reported the coil was pre-detached inside the microcatheter.There was no reported clinical consequence to the patient.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.The device was returned within the introducer sheath along with the microcatheter used in the procedure.Visual and microscopic inspection of the returned target device revealed that the proximal contact and delivery wire were kinked, likely due to handling.The suture was found to be damaged and the main coil was stretched and broken.The detachment zone was inspected and it was noted that the coil did not detach from the delivery wire; the coil broke below the detachment zone, and the remainder part of the coil was not returned or found in the microcatheter returned.A significant amount of blood was noted within the lumen of the microcatheter, which is consistent with insufficient flush maintained during the procedure; however, this could not be determined as the user indicated that continuous flush was maintained.Based on the information available, it is possible that the coil jammed in the microcatheter and a removal attempt caused the coil to stretch and break.Therefore, an assignable cause of procedural factors was assigned.

Event Description

It was reported the coil was pre-detached inside the microcatheter.There was no reported clinical consequence to the patient.

• Brand Name: TARGET 360 NANO 1.5MM X 2CM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 6905123
• MDR Text Key: 87860244
• Report Number: 3008881809-2017-00389
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K113412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: M0035421520
• Device Lot Number: 19414455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1