MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M0035421030

Device Problems Fracture (1260); Expulsion (2933)

Patient Problem Occlusion (1984)

Event Date 03/23/2020

Event Type  Injury  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that the coil (subject device) experienced difficulty advancing from the distal tip of the microcatheter and had fractured during use.Upon attempt of removal of microcatheter appeared to be protruded and occluded the vessel.The microcatheter was removed and the physician replaced the microcatheter and used a stent to adjust the protruded coil to return blood flow.The procedure completed without clinical consequences to the patient.

Manufacturer Narrative

It was confirmed that the same reported event, product had already been entered and captured under pi 2358937.Based on this update, this record 2360808 along with associated children will be cancelled due this duplicate entry.Refer to pi 2358937 for the continuation of the complaint process of the alleged issue associated with the subject complaint device.

Event Description

It was reported that the coil (subject device) experienced difficulty advancing from the distal tip of the microcatheter and had fractured during use.Upon attempt of removal of microcatheter appeared to be protruded and occluded the vessel.The microcatheter was removed and the physician replaced the microcathter and used a stent to adjust the protruded coil to return blood flow.The procedure completed without clinical consequences to the patient.

• Brand Name: TARGET 360 NANO 1MM X 3CM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9950332
• MDR Text Key: 187420306
• Report Number: 3008881809-2020-00099
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04546540697974
• UDI-Public: 04546540697974
• Combination Product (y/n): N
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0035421030
• Device Catalogue Number: M0035421030
• Device Lot Number: 21126755
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SL10 MICROCATHETER (STRYKER)
• Patient Outcome(s): Other; Required Intervention