MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 7MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0036127200

Device Problem Premature Separation (4045)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/03/2019

Event Type  Injury  

Manufacturer Narrative

The device history record 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.While there are several potential causes for the reported issues, because review and analysis of available information failed to identify a definitive cause, and because the device was not returned a cause of undeterminable was assigned.The device remains.

Event Description

It was reported that during embolization procedure for a gastric duodenal artery aneurysm, the physician felt coil (subject device) resistance inside the microcatheter and while attempting to retract the coil, it prematurely detached and remained inside the patient's vessel under the aneurysm.The physician completed the procedure with additional coil without any clinical consequences to the patient.No further information is available.

• Brand Name: TARGET XL 360 SOFT 7MM X 20CM
• 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: 9227546
• MDR Text Key: 163566506
• Report Number: 3008881809-2019-00322
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 07613327004632
• UDI-Public: 07613327004632
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2022
• Device Catalogue Number: M0036127200
• Device Lot Number: 21315512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2019
• 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