MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035421540
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the device returned with stryker microcatheter.There were no anomalies noted to the microcatheter.The coil delivery wire was found to be severely kinked/bent in multiply areas.Significant amount of dry blood on the coil delivery wire was noted.The main coil was found to be detached and not returned.The coil introducer sheath was not returned.Coil jammed functional test was unable to perform as the coil was found to be detached.An attempt was taken to remove the coil delivery wire for further analysis.Due to dry blood, it was not possible to flush the device.The coil delivery could not be advanced due to significant friction caused by dry blood.An attempt was taken to retract the coil delivery wire; however, it was not possible.The catheter was cut in a few places to remove the coil deliver wire.The coil delivery wire could be removed but it broke and was severely damaged during the analysis.The coil was found to be detached and not present inside the microcatheter.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 coil jammed could not be duplicated; 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 received indicated that the device was prepared for use as per the directions for use, the device was confirmed to be in good condition prior to use on the patient, continuous flush was set up and maintained and the patient¿s anatomy was described as 'moderately torturous'.The device was analyzed and the main coil was found to be detach and not returned.The coil delivery wire was found to be severely kinked/bent in multiply areas and stuck inside the microcatheter due to dry blood.It is very probable that insufficient flush and the moderately tortuous anatomy may have caused friction, damages to the device and the reported issue.An assignable cause of procedural factors will be assigned to the as reported 'coil jammed', and to the as analyzed codes 'main coil prematurely detached/separated during use', 'coil delivery wire kinked/bent', and 'coil delivery wire jammed' as this complaint 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
The coil (subject device) was returned for analysis, and it was discovered that the coil (subject device) was found to be prematurely detached during use.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET 360 NANO 1.5MM X 4CM
• 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: 18322760
• Report Number: 3008881809-2023-00580
• Device Sequence Number: 17924693
• Product Code: HCG
• UDI-Device Identifier: 04546540697998
• UDI-Public: 04546540697998
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/13/2023

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: 03/07/2026
• Device Catalogue Number: M0035421540
• Device Lot Number: 24214846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2023
• 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: ATLAS STENT (STRYKER).; MEDTRONIC MICROCATHETER (NON-STRYKER).; SL-10 MICROCATHETER (STRYKER).
• Patient Sex: Unknown
• Patient Race: Asian