MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 9MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M0036129300

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2018

Event Type  malfunction  

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.In the case of this complaint it is possible that the main coil encountered resistance while advancing through microcatheter and detached prematurely during retrieval due to some procedural factors encountered during use.Also as reported that a non-stryker microcatheter was used for performing the procedure which can also contribute to failure due to potential incompatibility of non-stryker devices, possibly leading to the reported main coil prematurely detached/separated inside patient, and coil in catheter friction.However it cannot be confirmed.As per additional information no damage was noted to the device prior to use and the device was prepared as per dfu (directions for use) for this product.Therefore; an assignable cause of ¿undeterminable¿ will be assigned to the reported event as the device was not returned and the review and analysis of all available information failed to indicate an assignable cause or probable assignable cause.The subject device is not available.

Event Description

It was reported that during a coil embolization procedure, the physician attempted to detach the coil, but the coil wasn¿t sitting in the aneurysm as the physician wanted and the coil was repositioned multiple times.Physician also mentioned that some resistance was observed inside the microcatheter.As the physician attempted to remove the coil, it detached within the microcatheter.The physician removed the detached coil along with the microcatheter without any clinical consequence to the patient.

• Brand Name: TARGET XL 360 SOFT 9MM X 30CM
• 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: 7244644
• MDR Text Key: 99194599
• Report Number: 3008881809-2018-00059
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04546540711618
• UDI-Public: (01)04546540711618(17)190131(10)18781549
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: M0036129300
• Device Catalogue Number: M0036129300
• Device Lot Number: 18781549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2016
• 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