MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 5MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M0036125100

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that when the coil was removed into the introducer sheath, the coil detached prematurely inside the microcatheter.The coil was retrieved along with the microcatheter.There were no reported clinical consequences to the patient.

Manufacturer Narrative

Manufacturing date ¿ added.Device evaluated by mfg ¿updated.Summary attached - updated.Expiration date - added.Product available to stryker ¿ updated.Returned to manufacturer on ¿updated.The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.Visual inspection revealed that the delivery wire was kinked/bent most likely due to the handling of the device.The main coil was not returned for analysis and the main coil was found to be detached due to a physical break at the detachment zone.There was procedural fluid was noted on the device as well.Functional testing could not be performed due to the damaged condition of the returned device.Information available indicated that continuous flush was not maintained during the procedure.It is likely that insufficient flush contributed to the damage noted to the device and to the reported issue.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 information available, an assignable cause of use error was assigned to this event.

Event Description

It was reported that when the coil was removed into the introducer sheath, the coil detached prematurely inside the microcatheter.The coil was retrieved along with the microcatheter.There were no reported clinical consequences to the patient.

• Brand Name: TARGET XL 360 SOFT 5MM X 10CM
• 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: 7146968
• MDR Text Key: 95851670
• Report Number: 3008881809-2017-00536
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 07613327128314
• UDI-Public: (01)07613327128314(17)190228(10)18859480
• Combination Product (y/n): N
• PMA/PMN Number: K123377
• 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: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: M0036125100
• Device Catalogue Number: M0036125100
• Device Lot Number: 18859480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2016
• 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
• Patient Age: 45 YR