MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036121040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
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.During visual and microscopic inspection, it was observed that the subject coil was returned, and the main coil was seen to be kinked and stretched.The subject coil delivery wire was seen to be broken/fractured and kinked/bent with detachment zone intact.The main coil was stuck inside the catheter and could not be removed.Functional testing could not be performed due to the damage noted to the subject coil.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 as reported codes main coil stretched and coil difficult to remove/withdraw from catheter was confirmed and as reported code device difficulty engaging target vessel could not be replicated during device analysis; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use.There was no damage noted to the packaging prior to opening the packaging and the device was confirmed to be in good condition during preparation/prior to use on the patient.The continuous flush was set up and maintained throughout the clinical procedure.On visual inspection the subject coil delivery wire was found to be kinked and broken/fractured.The main coil was seen to be kinked and stretched and stuck inside of the returned catheter.Based on a review of the available information and analysis of the returned device, it is probable that there may have been procedural/anatomical factors present, causing the reported issues during advancement of the device which led to the subsequent device damage.An assignable cause of procedural factors will be assigned to the as reported codes main coil stretched, coil difficult to remove/withdraw from catheter and device difficulty engaging target vessel and as analyzed codes main coil stretched, main coil kinked/bent, coil difficult to remove/withdraw from catheter and coil delivery wire broken/fracture during use as 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.An assignable cause of handling damage will be assigned to the as analyzed coil delivery wire kinked/bent since it is most likely that this damage occurred due to handling of delivery wire during the clinical procedure.
Event or Problem Description
It was reported that during an aneurysm procedure, operator had difficulty positioning the subject coil in the target location, and it could not be retracted.Therefore, the subject coil along with the microcatheter was removed from the patient¿s body and the subject coil was found stretched.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully with another device.The subject coil was returned for analysis and the device investigation revealed that the subject coil delivery wire was found to be broken/fractured during use.

• Brand Name: TARGET XL 360 SOFT 10MM 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: 18926794
• Report Number: 3008881809-2024-00112
• Device Sequence Number: 9445856
• Product Code: HCG
• UDI-Device Identifier: 07613327004601
• UDI-Public: 07613327004601
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2024

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: 05/28/2025
• Device Catalogue Number: M0036121040
• Device Lot Number: 23677955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2022
• 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: MARVEL MICROCATHETER (CARNELIAN)
• Patient Age: 59 YR
• Patient Sex: Male