MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 3MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035443060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
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.Visual/microscopic inspection indicated that the coil delivery wire was kinked/bent.The main coil was stretched.The main coil broken/fracture.The suture is seen to be damaged.Functional inspection indicated that introducer sheath test failed due to friction detection when advancing coil through 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 device was returned for analysis and coil was found stretched and broken/fractured and the suture was damaged.In the case of this complaint, it is most likely that anatomical or procedural factors resulted to friction during advancement/retraction of the coil and causing the coil stretched, suture damaged and then break during manipulation.The event 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.The ar (reported code) and aa (analyzed code) coil introducer sheath friction and main coil stretched, main coil suture damage &main coil broken/fractured during use will be assigned procedural factors.An assignable cause of handling damage will be assigned to the coil delivery wire kinked/bent as it is most likely that the delivery wire kinked due to handling of the device during use.
Event or Problem Description
Analysis of the returned device found that the main coil broken/fractured during use.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: TARGET 360 NANO 3MM 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: 12081779
• Report Number: 3008881809-2021-00279
• Device Sequence Number: 3348704
• Product Code: HCG
• UDI-Device Identifier: 07613252600329
• UDI-Public: 07613252600329
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/28/2021

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: 09/21/2023
• Device Model Number: M0035443060
• Device Catalogue Number: M0035443060
• Device Lot Number: 22454574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1