MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035422040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that when the surgeon removed the delivery wire (subject device) from the microcatheter, the surgeon felt a little resistance.When the surgeon pulled the delivery wire (subject device) out, he noticed that the delivery wire (subject device) had broken off.No fragment left inside the patient.The procedure was completed successfully without any problem.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, there was only part of the delivery wire returned, the delivery wire was returned with the coil detached, the coil delivery wire was seen to be broken.Functional test not carried out due to damage.The reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to 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.It was reported that during the procedure, resistance was felt during removal of the delivery wire from the microcatheter after successfully detaching the coil.When the delivery wire was pulled, it broke off at the hub of the microcatheter.Additional information provided by the customer indicated that preparation/set-up was performed as per the dfu, continuous flush was maintained for the duration of the procedure, the tapered distal end of the introducer sheath was firmly seated in the hub of the microcatheter (with a slight buckling or reactive force indicating proper positioning), the rhv was opened enough to allow passage of the device through without damage, an sl-10 microcatheter was used, the coil was detached with the inzone without any issues noted, no excessive force was applied at any point while advancing the coil within the microcatheter, and the tortuosity of the patient's anatomy was average.Only the distal portion of the delivery wire (where the main coil had detached from) was returned for analysis.The returned delivery wire was noted to be broken/fractured on its proximal end with the coil winding unraveled, confirming the reported event.Although functional testing could not be performed, the damage noted to the delivery wire is indicative of the reported friction.An assignable cause of procedural factors will be assigned to the as reported and as analyzed codes for this complaint since these issues are 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.
Event or Problem Description
It was reported that when the surgeon removed the delivery wire (subject device) from the microcatheter, the surgeon felt a little resistance.When the surgeon pulled the delivery wire (subject device) out, he noticed that the delivery wire (subject device) had broken off.No fragment left inside the patient.The procedure was completed successfully without any problem.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 ULTRA 2MM X 4CM
• 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: 12278613
• Report Number: 3008881809-2021-00325
• Device Sequence Number: 19983381
• Product Code: HCG
• UDI-Device Identifier: 04546540675842
• UDI-Public: 04546540675842
• 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: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

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: 09/29/2023
• Device Model Number: M0035422040
• Device Catalogue Number: M0035422040
• Device Lot Number: 22465588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 10/28/2021
• 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: SL-10 (STRYKER MANUFACTURER); SL-10 (STRYKER MANUFACTURER)