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

Model Number	M0035423060
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure of coil embolization for subarachnoid hemorrhage (sah), subject coil was advanced into microcatheter up to second indication marker.The physician then found that the detachment point had come out of the tip of the microcatheter.The physician's opinion was that the marker position or the length between tip of delivery wire and marker was incorrect.The procedure was completed without clinical consequences to the patient.
Event or Problem Description
It was reported that during the procedure of coil embolization for subarachnoid hemorrhage (sah), subject coil was advanced into microcatheter up to second indication marker.The physician then found that the detachment point had come out of the tip of the microcatheter.The physician's opinion was that the marker position or the length between tip of delivery wire and marker was incorrect.The procedure was completed without clinical consequences to the patient.
Additional Manufacturer Narrative
D4 expiration date ¿ added h3 device evaluated by mfg ¿updated h3 summary attached - updated h4 manufacturing date ¿ added due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 and the lot number was not confirmed as the packaging was not returned with the device.During visual inspection, the proximal contact wire was intact.The main coil was detached and the coil delivery wire was kinked/bent.Functional testing was not required as per procedure for this reported event.The as reported was not confirmed during analysis, the coil delivery wire was found to be kinked and the main coil was detached.The device was returned, and a review of analysis and all available information fails to indicate an assignable cause or probable assignable cause for the reported event, an assignable cause of not confirmed will be assigned to the as reported.The as analyzed 'coil delivery wire kinked/bent' and 'main coil prematurely detached/separated during use' will be assigned procedural factors as these defects appear 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.

• Brand Name: TARGET 360 ULTRA 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: 11128725
• Report Number: 3008881809-2021-00012
• Device Sequence Number: 3334760
• Product Code: HCG
• UDI-Device Identifier: 04546540675880
• UDI-Public: 04546540675880
• 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,Followup
• Report Date (Section B): 03/23/2021

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: 07/05/2023
• Device Model Number: M0035423060
• Device Catalogue Number: M0035423060
• Device Lot Number: 22329812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 03/23/2021
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)