MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035424080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2021
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 the procedure, the delivery wire of the coil (subject device) was found to be broken.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.D10 product available to stryker ¿ updated.D10 returned to manufacturer on ¿updated.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was received.The reported lot number was confirmed from the packaging label.During the visual inspection, the coil delivery wire was found to be kinked/ bent in a few places.There was no breakage/fracture noted.The main coil was found to be intact.The coil introducer sheath was found to be intact.Functional testing was not required.The reported event is covered in the device directions for use.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 delivery wire broken/fractured during use was not confirmed during the investigation.The device failed to meet specifications when received for complaint investigation.Additional information was provided by the customer stated that the device was confirmed to be in good condition during preparation/prior to use on the patient, device was prepared as per dfu, and the continuous flush was set up and maintained throughout the procedure.The device was analyzed.The delivery wire was found to be kinked/bent.No breakage noted.This complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu.An assignable cause of handling damage will be assigned to the as analyzed code "coil delivery wire kinked/bent" as this complaint appears to be associated with handling of the product or portion of the product during the procedure.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that during the procedure, the delivery wire of the coil (subject device) was found to be broken.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 ULTRA 4MM X 8CM
• 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: 13003245
• Report Number: 3008881809-2021-00527
• Device Sequence Number: 17364183
• Product Code: HCG
• UDI-Device Identifier: 04546540675927
• UDI-Public: 04546540675927
• 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): 03/28/2022

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: 11/01/2023
• Device Model Number: M0035424080
• Device Catalogue Number: M0035424080
• Device Lot Number: 22561606
• 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: 11/25/2021
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2020
• 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
• Patient Sex: Unknown