MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK MATRIX2 ULTRASOFT SR 3MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M003497320SR0

Device Problem Premature Activation (1484)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2018

Event Type  Injury  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that the coil (subject device) prematurely detached inside the patient during the procedure.The coil was retrieved along with the microcatheter using a goose neck snare device.The procedure was completed successfully using a different coil.There were no reported clinical consequences to the patient.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was returned within the within a competitor microcatheter (prowler14) and goose neck snare.Visual inspection of the device revealed that the main coil was noted detached from the delivery wire and severely stretched, entrapped with a goose neck snare.There was procedural fluid noted within the microcatheter hub as well.During functional testing, the snare was unable to be removed from the returned microcatheter and the microcatheter was cut in an attempt to remove the snare, but it was not possible.After flushing the microcatheter, a 0.0158¿ patency mandrel was able to be advanced into the hub and proximal end of microcatheter without any difficulty.Information available indicated that the coil was confirmed to be in good condition prior to use.The presence of procedural fluid in the microcatheter entrapped with the coil and goose neck snare is an indication that continuous flush was not maintained.The lack of continuous flush could have caused the reported and analyzed issues; however, information available indicated that continuous flush was maintained and it cannot be determined if this continuous flush was present prior to medical intervention.Based on this information, the cause of the reported and analyzed anomalies could not be definitively determined.

Event Description

It was reported that the coil (subject device) prematurely detached inside the patient during the procedure.The coil was retrieved along with the microcatheter using a goose neck snare device.The procedure was completed successfully using a different coil.There were no reported clinical consequences to the patient.

• Brand Name: MATRIX2 ULTRASOFT SR 3MM X 20CM
• 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: 7382255
• MDR Text Key: 103855203
• Report Number: 3008881809-2018-00138
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04546540691699
• UDI-Public: (01)04546540691699(17)190331(10)19015180
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K050700
• 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: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: M003497320SR0
• Device Catalogue Number: M003497320SR0
• Device Lot Number: 19015180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2016
• 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
• Treatment: PROWLER MICROCATHETER(CODMAN)
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR