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

Model Number	M0035424150
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that the coil (subject device) was prematurely detached inside the microcatheter during use.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that the coil (subject device) was prematurely detached inside the microcatheter during use.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
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 coil delivery wire was kinked / bent and the main coil was kinked / bent and stretched.Functional inspection was not carried out due to damage of returned device.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to 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.It was reported that the coil (subject device) was prematurely detached inside the microcatheter during coil preparation.Additional information provided by the customer indicated that the device was prepared as per the dfu, continuous flush was maintained, and the tip of the coil was damaged.Analysis of the returned device revealed that the main coil was not detached / separated from the delivery wire.Therefore, the reported main coil prematurely detached / separated during use was not confirmed.It is possible that the damage to the main coil may have been mistaken as a partially detached coil.Based on the investigation, the main coil likely kinked during advancement in the microcatheter due to some procedural factors and then stretched upon repositioning.An assignable cause of procedural factors will be assigned to the as analyzed main coil kinked/bent and main coil stretched since these defects appear to be associated with a product that met design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and / or anatomical factors during use.An assignable cause of handling damage will be assigned to the coil delivery wire kinked / bent since this defect appears to be associated with handling at the proximal end of the device during use.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• 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
• MDR Report Key: 10753389
• Report Number: 3008881809-2020-00319
• Device Sequence Number: 3486416
• Product Code: HCG
• UDI-Device Identifier: 04546540675941
• UDI-Public: 04546540675941
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 01/03/2021

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: 01/19/2023
• Device Model Number: M0035424150
• Device Catalogue Number: M0035424150
• Device Lot Number: 22075642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 01/03/2021
• 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).; MICROCATHETER (UNKNOWN MANUFACTURER)
• Patient Age: 83 YR
• Patient Weight: 60