MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035424150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 main coil was found to be broken/fractured and stretched.The delivery wire was kinked/bent and the main coil suture was damaged.The introducer sheath was intact.Dimensional inspection confirmed the delivery wire length and introducer sheath tip id were within specification.The main coil od and length could not be measured due to the damage.The functional test for the reported 'main coil friction' could not be performed due to the condition of 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.The reported event 'main coil friction' could not be confirmed; however, the analysis results are consistent with the reported event.The reported 'main coil stretched' was confirmed during analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The device was analyzed.The main coil was found to be broken/fractured and stretched.The main coil suture was found to be damaged.The coil delivery wire as found to be kinked/bent.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 as reported (ar) 'main coil friction', ar/as analyzed (aa) code 'main coil stretched', and to the aa 'main coil broken/fractured during use' and 'main coil suture damage'.As assignable cause of handing damage will be assigned to the 'coil delivery wire kinked/bent' as this defect appears to be associated with handling of the product or portion of the product during the procedure.
Event or Problem Description
The subject coil was returned for analysis and it was discovered that the main coil was broken/fractured during use.No clinical consequences were reported to the patient as a result of this event.

• Brand Name: TARGET 360 ULTRA 4MM X 15CM
• 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: 15874292
• Report Number: 3008881809-2022-00597
• Device Sequence Number: 2492281
• Product Code: HCG
• UDI-Device Identifier: 04546540675941
• UDI-Public: 04546540675941
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 11/28/2022

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: 01/04/2025
• Device Model Number: M0035424150
• Device Catalogue Number: M0035424150
• Device Lot Number: 23394043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2022
• 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: 6F LONG SHEATH (UNKNOWN); AXS CATALYST CATHETER (STRYKER); SL-10 MICROCATHETER (STRYKER); SYNCHRO GUIDEWIRE (STRYKER)
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Race: Asian