MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 2.0MM X 3.5CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5412035
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes), there are controls in the manufacturing process to ensure the product met specifications upon release.During visual/microscopic inspection, the main coil was seen to be broken fractured just at the detachment zone with partial coil still attached.There were no other anomalies noted to the device.During functional inspection, main coil prematurely detached/separated during use functional test was not confirmed.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 main coil prematurely detached/separated during use was not confirmed during analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The device was prepared for use as per the dfu.There was no damage noted to the packaging prior to opening the packaging.Continued flush was maintained throughout the procedure.The patient¿s anatomy was normal.During analysis, the main coil was seen to be broken/fractured just after the detachment zone with partial coil still attached.An assignable cause of ¿not confirmed¿ will be assigned to the as reported ¿main coil prematurely detached/separated during use¿, as the main coil was still partially attached along with the detachment zone.An assignable cause of ¿procedural factors¿ will be assigned to the as analyzed ¿main coil broken/fractured during use¿ these defects appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.
Event or Problem Description
It was reported that during the right anterior communicating artery aneurysm procedure the subject coil detached prematurely within the microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET TETRA 2.0MM X 3.5CM
• 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: 18843922
• Report Number: 3008881809-2024-00090
• Device Sequence Number: 18230562
• Product Code: HCG
• UDI-Device Identifier: 07613327578584
• UDI-Public: 07613327578584
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K222533
• 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): 03/06/2024

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 Expiration Date: 09/17/2026
• Device Catalogue Number: TG5412035
• Device Lot Number: 24539880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Sex: Male