MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M0036125150

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2017

Event Type  Injury  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that the coil detached prematurely inside the microcatheter during manipulation.The coil was retrieved with a snare and the procedure was completed successfully.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.Visual inspection of the device revealed that the delivery wire was kinked, likely due to handling.The main coil appears to have detached due to a physical break at the detachment zone.The main coil was found to be stretched as well.Functional testing could not be performed due to the damaged condition of the returned coil.The delivery wire was also noted to have been rotated could have led to the reported premature detachment within the microcatheter.Based on the information currently available, it is probable that some procedural factors encountered during the procedure limited the performance of the coil contributing to the reported and observed damages.Therefore, an assignable cause of operational context has been assigned to this investigation.

Event Description

It was reported that the coil detached prematurely inside the microcatheter during manipulation.The coil was retrieved with a snare and the procedure was completed successfully.There were no reported clinical consequences to the patient.

• Brand Name: TARGET XL 360 SOFT 5MM X 15CM
• 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: 7085431
• MDR Text Key: 93803849
• Report Number: 3008881809-2017-00508
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 07613327128291
• UDI-Public: (01)07613327128291(17)181031(10)18634526
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: M0036125150
• Device Catalogue Number: M0036125150
• Device Lot Number: 18634526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2015
• 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 Outcome(s): Required Intervention