MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1.5MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035431530
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2020
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 delivery wire was found to be kinked/bent and the main coil found to be broken/fractured and kinked/bent.The functional testing was unable to perform as the device problem is unknown/clear; however, the friction was noted during advancing the coil through the introducer sheath to complete the analysis.The reported event could not be confirmed as the reported issue is unknown.There was no allegation of failure or malfunction against this device, therefore a labelling review and a risk analysis could not be performed.Although the device problem is unknown, it was noted that friction was experienced when advancing the coil through the introducer sheath to complete analysis of the device.An assignable cause of procedural factors was assigned to the reported event device problem unknown/ unclear, and the analyzed events main coil kinked/bent, coil introducer sheath friction and main coil broken/fractured during use, as the issue is associated with a product that meets stryker design and manufacture specifications and is likely to have been used in according with the dfu but due to procedural factors during use, the product performance was limited.The as analyzed defect coil delivery wire kinked bent was assigned handling damage as this issue is likely due to handling of the product in response to the friction issue noted.
Event or Problem Description
Analysis of the returned device found that the main coil broken/fractured.There was no clinical consequence to the patient as a result of this event.

• Brand Name: TARGET HELICAL NANO 1.5MM X 3CM
• 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: 12776074
• Report Number: 3008881809-2021-00471
• Device Sequence Number: 6025755
• Product Code: HCG
• UDI-Device Identifier: 04546540698049
• UDI-Public: 04546540698049
• 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: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/08/2021

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: 05/20/2022
• Device Model Number: M0035431530
• Device Catalogue Number: M0035431530
• Device Lot Number: 21449140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2019
• 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