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

Catalog Number	M0035442040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported during the procedure, the physician encountered resistance during coil (subject device) placement in the aneurysm and the coil (subject device) got stuck.Upon removal of the microcatheter, a small piece was noticed separated from the subject coil (collected).No further information is available.
Event or Problem Description
It was reported during the procedure, the physician encountered resistance during coil (subject device) placement in the aneurysm and the coil (subject device) got stuck.Upon removal of the microcatheter, a small piece was noticed separated from the subject coil (collected).No further information is available.
Additional Manufacturer Narrative
C2 / d10 concomitant products grid: updated d4 expiration date - added d9 returned to manufacturer on - updated d9 product available to stryker ¿ updated h4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated h3 summary attached - updated there are controls in the manufacturing process to ensure the product met specifications upon release.The device was received, and the reported lot number was confirmed from the packaging label.During visual inspection, the coil delivery wire was noted to be kinked.The main coil was seen to be broken.The main coil was seen to be kinked at the proximal end.Functional testing was not completed due to device condition.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 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.Additional information provided by the customer is the device was prepared for use as per the dfu.There was no damage noted to the packaging prior to opening the packaging.The device was confirmed to be in good condition during preparation/ prior to use on the patient.Continuous flush was set up and maintained throughout the clinical procedure.During analysis, the main coil was noted to be broken/fractured and kinked, the delivery wire was also kinked in two locations towards the middle of the delivery wire.An assignable cause of procedural factors will be assigned to the as reported code of coil in catheter friction as this defect 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.An assignable cause of procedural factors will be assigned to the as analyzed code of main coil kinked as this defect 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.An assignable cause of handling damage will be assigned to the as analyzed code of coil delivery wire kinked/bent as this defect appears to be associated with handling of the product or portion of the product during preparation.

• Brand Name: TARGET 360 NANO 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
• 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: 18196162
• Report Number: 3008881809-2023-00561
• Device Sequence Number: 17780438
• Product Code: HCG
• UDI-Device Identifier: 07613252600299
• UDI-Public: 07613252600299
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 01/11/2024

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: 07/15/2026
• Device Catalogue Number: M0035442040
• Device Lot Number: 24431621
• 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: 11/15/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR XT-17 MICROCATHETER (STRYKER); MICROCATHETER (UNKNOWN)
• Patient Sex: Unknown