MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 14MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0036121450

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

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

Event Date 06/12/2018

Event Type  Injury  

Manufacturer Narrative

The subject device is not available.

Event Description

During the coil embolization procedure, it was reported that the coil was prematurely detached inside the patient when it was being reheated.Therefore, the physician used a retriever device to remove the detached coil from the patient.The procedure was aborted and then resumed the other day.No clinical consequences reported to the patient.

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.Information available indicated that the device was prepared as per the dfu (direction for use) and was in a good condition prior to use.Based on the information currently available the exact cause for the reported event cannot be determined.

Event Description

During the coil embolization procedure, it was reported that the coil was prematurely detached inside the patient when it was being resheathed.Therefore, the physician used a retriever device to remove the detached coil from the patient.The procedure was aborted and then resumed the other day.No clinical consequences reported to the patient.

• Brand Name: TARGET XL 360 SOFT 14MM X 50CM
• 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: 7660384
• MDR Text Key: 113081191
• Report Number: 3008881809-2018-00296
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04546540711540
• UDI-Public: 04546540711540
• 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: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: M0036121450
• Device Lot Number: 20265398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2018
• 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
• Treatment: MICROCATHETER (UNKNOWN MANUFACTURER)
• Patient Outcome(s): Required Intervention