MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421520
Medical Device Problem Codes	Fracture (1260); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during coil embolization procedure for a ruptured cerebral artery aneurysm, after several coils were placed in the aneurysm, there was resistance when the subject coil was advanced through the microcatheter and when retrieved the subject coil detached prematurely inside the tip of the microcatheter.The detached subject coil was removed from the patient vasculature along with the microcatheter and the procedure was completed without further treatment.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during coil embolization procedure for a ruptured cerebral artery aneurysm, after several coils were placed in the aneurysm, there was resistance when the subject coil was advanced through the microcatheter and when retrieved the subject coil detached prematurely inside the tip of the microcatheter.The detached subject coil was removed from the patient vasculature along with the microcatheter and the procedure was completed without further treatment.No clinical consequences were reported to the patient due to this event.
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.The device was returned and the lot number was confirmed with the packaging.During visual inspection, the delivery wire was seen to be kinked/bent.The coil was seen to be still attached to the delivery wire but was seen to be broken/fractured.The coil was seen to be stretched.During device analysis, the coil delivery wire was seen to be kinked, the coil was returned still attached to the coil delivery wire but was found to be broken and stretched.In the case of this complaint it is most likely that when the device encountered friction within the catheter the damage was caused to the delivery wire and main coil due to handling and manipulation of the 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 reported coil prematurely detached/separated during use was not confirmed during analysis.The reported coil in catheter friction could not be confirmed; however, the analysis results are consistent with the reported event.The device failed to meet specification when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer was that the device was prepared as per the dfu, that there was no damage noted to the packaging prior to opening and the device was confirmed to be in good condition during preparation/prior to use on the patient, and that continuous flush was set up and maintained during the procedure.Therefore the as reported event of coil in catheter friction, as well the as analyzed events of main coil broken/fractured during use and main coil stretched will be assigned procedural factors 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.The as analyzed event of coil delivery wire kinked bent will be assigned handling damage as the issue is due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.An assignable cause of not confirmed will be assigned to the as reported event of main coil prematurely dethatched/separated during use as the coil was returned still attached to the coil delivery wire.

• Brand Name: TARGET 360 NANO 1.5MM X 2CM
• 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: 14470245
• Report Number: 3008881809-2022-00238
• Device Sequence Number: 4904096
• Product Code: HCG
• UDI-Device Identifier: 04546540697981
• UDI-Public: 04546540697981
• 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,Followup
• Report Date (Section B): 08/05/2022

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: 01/03/2025
• Device Model Number: M0035421520
• Device Catalogue Number: M0035421520
• Device Lot Number: 23390724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2022
• 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: SL-10 MICROCATHETER (STRYKER); SL-10 MICROCATHETER (STRYKER)
• Patient Sex: Unknown