MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 14MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036101450
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Analysis of the returned device found that the main coil (subject device) was prematurely detached during use.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully.
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 coil delivery wire was found to be kinked/bent.The main coil was seen to have.The main coil was seen to be detached/separated.Functional inspection was unable to perform due to damage of device.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 device was analyzed, the coil delivery wire was noted to be kinked/bent and the main coil was returned detached.There were no anomalies on the coil.There was no information on the coil being detached therefore, during use will be assigned.The as reported ¿coil in catheter friction¿ could not be confirmed/replicated; however, the analysis results are consistent with the reported event.An assignable cause of procedural factors will be assigned to the as reported ¿coil in catheter friction' and as analyzed ¿main coil prematurely detached/separated 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 not confirmed will be assigned to the as reported ¿main coil stretched' as the event was not confirmed during the analysis only the coil proximal wire was broken/fractured.An assignable cause of handling damage will be assigned to the as analyzed ¿coil delivery wire kinked/bent¿ as the issue is due to handling of the product or portion of the product during the clinical procedure.

• Brand Name: TARGET XL 360 STANDARD 14MM X 50CM
• 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: 17390680
• Report Number: 3008881809-2023-00375
• Device Sequence Number: 18387192
• Product Code: HCG
• UDI-Device Identifier: 04546540711298
• UDI-Public: 04546540711298
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/25/2023

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: 03/22/2025
• Device Catalogue Number: M0036101450
• Device Lot Number: 23539957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2022
• 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: ESTREAM2MARKS MICROCATHETER (UNKNOWN)
• Patient Sex: Unknown