MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 2MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035452060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2020
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 introducer sheath was found bent and the main coil was noted broken.The main coil was also noted kinked/bent and there was procedural fluid present.During functional testing, the friction was felt when advancing the coil through the introducer sheath.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 initial reported defect was not confirmed; however, the analysis results are consistent with the event.The initial reported issue coil delivery wire friction and as analyzed issues coil introducer sheath kinked/bent, main coil broken/fractured during use, main coil kinked/bent, and coil introducer sheath friction will be assigned procedural factors as the defect appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural or anatomical factors during use.
Event or Problem Description
Analysis of the returned device found that the main coil was found broken/fractured.There was no clinical consequences to the patient as a result of this event.

• Brand Name: TARGET HELICAL NANO 2MM X 6CM
• 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: 10688565
• Report Number: 3008881809-2020-00305
• Device Sequence Number: 3907666
• Product Code: HCG
• UDI-Device Identifier: 07613252600381
• UDI-Public: 07613252600381
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 10/16/2020

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: 04/13/2022
• Device Model Number: M0035452060
• Device Catalogue Number: M0035452060
• Device Lot Number: 21371822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1