MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 12MM X 45CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036101240
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the coil (subject device) was pre-detached during procedure and the coil (subject device) remained in patient.There were no clinical consequences reported to the patient due to this event.No further information available at this time.
Event or Problem Description
It was reported the coil (subject device) was pre-detached during procedure and the coil (subject device) remained in patient.There were no clinical consequences reported to the patient due to this event.No further information available at this time.
Additional Manufacturer Narrative
D4 expiration date - added.D9/h3 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.H4 manufacturing date ¿ added.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual inspection of the returned device revealed that the coil delivery wire and the proximal contact were seen to be severely kinked/bent.Additionally, the main coil was seen to be detached/separated.The device was returned very tangled up and while trying to detangle it the coil delivery wire broke/fractured during analysis.The functional testing could not be performed due to the condition of the returned 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.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient, the device was prepared as per the dfu, continuous flush was set up and maintained and the patients anatomy was described as normal'.An excelsior sl-10 microcatheter was used with the coil device and this catheter performed as intended.This was the first coil being used in the procedure and it was necessary for the physician to embolize the target vessel and leave the detached coil in-situ inside the patient.During analysis, it was noted that both the delivery wire and proximal contact were kinked/bent.Based on the investigation, 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.Therefore, an assignable cause of procedural factors will be assigned to the reported event and to the analyzed 'main coil prematurely separated/detached during use'.An assignable cause of handling damage will be assigned to the 'coil delivery wire kinked/bent' and 'coil proximal contact kinked/bent' as it is most likely that this damage occurred due to handling of the device during use.

• Brand Name: TARGET XL 360 STANDARD 12MM X 45CM
• 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: 11971101
• Report Number: 3008881809-2021-00239
• Device Sequence Number: 1153382
• Product Code: HCG
• UDI-Device Identifier: 04546540711281
• UDI-Public: 04546540711281
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2021

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: 09/22/2022
• Device Model Number: M0036101240
• Device Catalogue Number: M0036101240
• Device Lot Number: 21748584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 09/13/2021
• 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: MICROCATHETER (UNKNOWN MANUFACTURER); MICROCATHETER (UNKNOWN MANUFACTURER)