MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035476200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the delivery wire of the coil (subject device) fractured during the procedure.The subject coil failed to be detached due to the fracture on the delivery wire.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.During visual inspection, the proximal contact wire was intact but the introducer sheath was kinked/bent.The main coil was detached from the delivery wire but was noted to be intact.Several kink were present along the coil delivery wire and the proximal contact was noted to be broken/fractured.Functional testing was not possible as the main coil was noted to be detached from the coil delivery wire.The detachment zones were examined and were noted to be electrolytically detached.The reported defect main coil failed/unable to detach was not confirmed during analysis.However, the analysis results are consistent with the event.The delivery wire was kinked bent.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 defect coil delivery wire broken/fractured was confirmed based on the returned device.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was confirmed that the proximal contact was broken/fractured within the inzone.Also, it was confirmed that the target coil had been electrolytically detached, however as it was returned with the target coil, it is probable that it may have been partially detached at the detachment zone, allowing it to be removed with the delivery wire, upon removal from the patient.An assignable cause of procedural factors will be assigned to the reported main coil failed/unable to detach, and the analyzed coil introducer sheath kinked/bent.It is probable that the proximal contact detached as a result of handling of the device during preparation of the device or during advancement of the device.An assignable cause of handling damage will be assigned to the reported coil delivery wire broken/ fractured during use and the analyzed defects coil delivery wire kinked/bent & coil proximal contact wire broken/fractured.
Event or Problem Description
It was reported that the delivery wire of the coil (subject device) fractured during the procedure.The subject coil failed to be detached due to the fracture on the delivery wire.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET 360 SOFT 6MM X 20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10948184
• Report Number: 3008881809-2020-00379
• Device Sequence Number: 3189425
• Product Code: HCG
• UDI-Device Identifier: 04546540676542
• UDI-Public: 04546540676542
• 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,Followup
• Report Date (Section B): 03/28/2021

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: 06/09/2023
• Device Model Number: M0035476200
• Device Catalogue Number: M0035476200
• Device Lot Number: 22309885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2020
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 03/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR SL-10 MICROCATHETER (STRYKER); INZONE DETACHMENT SYSTEM (STRYKER)
• Patient Age: 43 YR