MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 12MM X 45CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M0036121240

Device Problem Premature Activation (1484)

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

Event Date 03/13/2018

Event Type  Injury  

Manufacturer Narrative

Subject device is not available.

Event Description

It was reported the coil prematurely detached and the physician had to use a lasso snare to retrieve the coil from the patient.No additional information is available.

Manufacturer Narrative

Product available to stryker - device received, updated to 'return'.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Inspection of the returned device found the delivery wire was kinked, likely due to handling, and the main coil was prematurely detached.Additional information stated the main coil detached before it could be retracted into the microcatheter, indicating the coil was being repositioned.Based on device analysis and information available, it is probable the device was damaged during the procedure, possibly due to excessive force, and the coil detached due to a physical break at the main coil junction.As such, ¿cause traced to component failure' was assigned to this investigation.

Event Description

It was reported the coil prematurely detached and the physician had to use a lasso snare to retrieve the coil from the patient.No additional information is available.

• Brand Name: TARGET XL 360 SOFT 12MM X 45CM
• 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: 7473537
• MDR Text Key: 106915467
• Report Number: 3008881809-2018-00195
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04546540711533
• UDI-Public: (01)04546540711533(17)210131(10)20227774
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K153658
• 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: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: M0036121240
• Device Catalogue Number: M0036121240
• Device Lot Number: 20227774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2018
• 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: LASSO SNARE (UNKNOWN MANUFACTURER)
• Patient Outcome(s): Required Intervention