MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 8MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036180820
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Additional information provided by the customer was "the coil was trying to be filling in the target side, the size did not fit, and when an attempt was made to retrieve the coil, it got prematurely detached within the microcatheter.It was removed with the entire microcatheter and replaced with a new one".It was also reported was the device was prepared as per the directions for use, there was no damage noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned to the as reported event.
Event or Problem Description
It was reported that during the procedure the coil (subject device) detached prematurely within the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET XXL 360 8MM X 20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 16588345
• Report Number: 3008881809-2023-00149
• Device Sequence Number: 17659323
• Product Code: HCG
• UDI-Device Identifier: 07613327466416
• UDI-Public: 07613327466416
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161429
• 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): 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/23/2024
• Device Model Number: M0036180820
• Device Catalogue Number: M0036180820
• Device Lot Number: 21536979R
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown