MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 8MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036180840
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional inspections were not performed due to the device was not returned.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.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.It was reported that premature detachment occurred after repositioning the subject coil twice.Part of the coil remained in the microcatheter, so negative pressure was applied to retrieve it.A new coil of the same type was then taken out and used without any problem and the procedure was completed successfully using the same microcatheter.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared for use as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, and the coil was advanced slowly and gently without applying excessive force.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned for analysis, an assignable cause of undeterminable was assigned to the reported event ¿main coil prematurely detached/separated during use'.
Event or Problem Description
It was reported that during hepatic artery coil embolization procedure the subject coil was repositioned twice, after which it prematurely detached inside the microcatheter.Negative pressure was applied to retrieve the subject coil from the microcatheter.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XXL 360 8MM X 40CM
• 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: 19767731
• Report Number: 3008881809-2024-00329
• Device Sequence Number: 8605241
• Product Code: HCG
• UDI-Device Identifier: 07613327466423
• UDI-Public: 07613327466423
• 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): 07/17/2024

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 Catalogue Number: M0036180840
• Device Lot Number: 24619822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LIGHTHOUSE MICROCATHETER (NON-STRYKER).
• Patient Sex: Unknown