MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0035422060

Device Problems Migration or Expulsion of Device (1395); Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2017

Event Type  malfunction  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that during the coil embolization procedure, the main coil detached prematurely inside the microcatheter and arrived in the lumen of the artery.There were no reported clinical consequences to the patient.

Manufacturer Narrative

The device history record review could not be performed since the lot number was not known.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.The cause of the reported issue could not be definitively determined.

Event Description

It was reported that during the coil embolization procedure, the main coil detached prematurely inside the microcatheter and arrived in the lumen of the artery.There were no reported clinical consequences to the patient.

• Brand Name: TARGET 360 ULTRA 2MM X 6CM
• 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: 7072152
• MDR Text Key: 93489870
• Report Number: 3008881809-2017-00502
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M0035422060
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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