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

Catalog Number	M0036127200
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/03/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 9227546
• Report Number: 3008881809-2019-00322
• Device Sequence Number: 13936886
• Product Code: HCG
• UDI-Device Identifier: 07613327004632
• UDI-Public: 07613327004632
• Combination Product (Y/N): N
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2022
• Device Catalogue Number: M0036127200
• Device Lot Number: 21315512
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1