MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035425150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2020
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.The device was returned with a dispenser coil.The lot number was confirmed with the packaging returned with the device.On visual inspection, the delivery wire & proximal contact wire were intact.Several kinks were present along the coil delivery wire.The main coil was stretched, kinked and broken.Procedural fluids were also present.The suture was damaged.Functional testing could not be performed as the coil was severely damaged.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 the coil was found stretched, kinked/bent, suture was also damaged and coil broken.In the case of this complaint, it is most likely that anatomical or procedural factors resulted in the target coil stretched, kinked/bent, damaged suture and eventually broke/fractured when trying to remove.This complaint 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 factors during use.Therefore an assignable cause of procedural factors will be assigned to the as reported and as analyzed events.An assignable cause of handling damage will be assigned to the as analyzed 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
It was reported that during the procedure, the subject coil was stretched.It was initially reported that during the procedure, the subject coil was stretched.Analysis of the device revealed that the subject main coil was broken/fractured during use.There was no clinical consequence to the patient as a result of this event.

• Brand Name: TARGET 360 ULTRA 5MM X 15CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 10389216
• Report Number: 3008881809-2020-00237
• Device Sequence Number: 2060658
• Product Code: HCG
• UDI-Device Identifier: 04546540675965
• UDI-Public: 04546540675965
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• 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): 08/11/2020

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: 12/04/2022
• Device Model Number: M0035425150
• Device Catalogue Number: M0035425150
• Device Lot Number: 21996118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER (UNKNOWN MANUFACTURER)