MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 5 MM X 10 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0035475100

Device Problem Premature Activation (1484)

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

Event Date 12/21/2017

Event Type  Injury  

Manufacturer Narrative

Subject device is not available.

Event Description

It was reported that during coil embolization of an aneurysm, the coil (subject device) was unable to be detached after 2 detachment attempts.The delivery wire was withdrawn carefully, but the coil prematurely detached during withdrawal.The physician cut off the microcatheter hub and removed the coil by using a gooseneck snare device.The coil and microcatheter were replaced in order to finish the procedure.There was no clinical consequences to the patient.

Manufacturer Narrative

The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.Information from the complaint indicated that no anomalies were noted to the device prior to use.Based on the information available and considering that the device was not returned, the exact cause for the reported event cannot be determined.

Event Description

It was reported that during coil embolization of an aneurysm, the coil (subject device) was unable to be detached after 2 detachment attempts.The delivery wire was withdrawn carefully, but the coil prematurely detached during withdrawal.The physician cut off the microcatheter hub and removed the coil by using a gooseneck snare device.The coil and microcatheter were replaced in order to finish the procedure.There was no clinical consequences to the patient.

• Brand Name: TARGET 360 SOFT 5 MM X 10 CM
• 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: 7184703
• MDR Text Key: 97048647
• Report Number: 3008881809-2018-00034
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K102672
• 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: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: M0035475100
• Device Lot Number: 19984263
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2017
• 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
• Patient Age: 65 YR