MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035422060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure resistance was encountered when advancing the subject coil through the microcatheter shaft.When the physician was removing the coil from the microcatheter, the coil detached due to the resistance encountered while pulling the coil out.The coil and microcatheter were replaced and the procedure were completed successfully.There were no clinical consequences to the patient reported as a result of this event.
Additional Manufacturer Narrative
D4 expiration date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.H4 manufacturing date ¿ added.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the delivery wire was found to be kinked/bent and the main coil was found detached.Functional testing was not performed since the main coil was found detached.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 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.Continuous flush was set up and maintained during the clinical procedure and the patient¿s anatomy was described as moderately tortuous.The delivery wire was noted to be kinked/bent and the main coil was noted to be missing from the distal end of the delivery wire.A detached main coil was found inside the catheter lumen during analysis of the excelsior sl-10 microcatheter that was used in the procedure.Congealed blood was observed in the catheter hub and blood clots were also visible on the recovered coil as noted.This suggests that insufficient flush may have been a contributing factor in this complaint.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 and/or anatomical factors during use.Therefore, an assignable cause of procedural factors will be assigned to the as reported issue coil in catheter friction, coil difficult to remove/withdraw from catheter, and main coil prematurely separated/detached during use and to the as analyzed issues main coil prematurely detached/separated during use.An assignable cause of handling damage was assigned to the as analyzed issue coil delivery wire kinked/bent as it is most likely that the delivery wire damage occurred due to handling of the device during use.
Event or Problem Description
It was reported that during the procedure resistance was encountered when advancing the subject coil through the microcatheter shaft.When the physician was removing the coil from the microcatheter, the coil detached due to the resistance encountered while pulling the coil out.The coil and microcatheter were replaced and the procedure were completed successfully.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: TARGET 360 ULTRA 2MM X 6CM
• 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: 11704489
• Report Number: 3008881809-2021-00171
• Device Sequence Number: 4331047
• Product Code: HCG
• UDI-Device Identifier: 07613252239345
• UDI-Public: 07613252239345
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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): 07/26/2021

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: 01/11/2024
• Device Model Number: M0035422060
• Device Catalogue Number: M0035422060
• Device Lot Number: 22679432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 07/27/2021
• 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)