MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3.5MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0035423580

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2018

Event Type  malfunction  

Manufacturer Narrative

The subject device is not available.

Event Description

During the procedure, it was reported that the coil was prematurely detached and stretched in the microcatheter.No clinical consequences reported to the patient.No further information is available for now.

Manufacturer Narrative

The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.As per additional information no damage was noted to the device prior to use and the device was prepared as per dfu (direction for use) for this product.Based on the information currently available the exact cause for the reported main coil prematurely detached/separated inside patient and main coil stretched cannot be determined.

Event Description

During the procedure, it was reported that the coil was prematurely detached and stretched in the microcatheter.No clinical consequences reported to the patient.No further information is available for now.

• Brand Name: TARGET 360 ULTRA 3.5MM X 8CM
• 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: 7334827
• MDR Text Key: 102319626
• Report Number: 3008881809-2018-00106
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: M0035423580
• Device Lot Number: 18342675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2015
• 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