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

Model Number	M0035423060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device remains implanted.
Event or Problem Description
It was reported that the subject coil was used during emergency embolism after pancreatectomy.Resistance was reported when advancing the subject coil through the microcatheter.The physician was able to place the subject coil in the target site and when tried to detach the coil using the detachment system after confirming the position of the marker, long beep continued, and the coil could not be detached.The physician tried to detach the coil 5 to 6 times; however; similar event occurred.The physician pulled the coil slowly but it detached inside the microcatheter.The delivery wire of the coil was removed, and the subject coil was pushed into the vessel using a guidewire.Other products were used to complete the procedure successfully.There was no patient injury 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.Visual and functional testing could not be performed since the device was not returned for investigation.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.Additional information provided by the customer indicated that continuous flush was maintained throughout the procedure.As per the complaint details, a non-stryker microcatheter was used which may have contributed to the failure.This however, cannot be confirmed.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned to this complaint.
Event or Problem Description
It was reported that the subject coil was used during emergency embolism after pancreatectomy.Resistance was reported when advancing the subject coil through the microcatheter.The physician was able to place the subject coil in the target site and when tried to detach the coil using the detachment system after confirming the position of the marker, long beep continued, and the coil could not be detached.The physician tried to detach the coil 5 to 6 times; however; similar event occurred.The physician pulled the coil slowly but it detached inside the microcatheter.The delivery wire of the coil was removed, and the subject coil was pushed into the vessel using a guidewire.Other products were used to complete the procedure successfully.There was no patient injury due to this event.

• 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: 10633116
• Report Number: 3008881809-2020-00284
• Device Sequence Number: 19442803
• 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
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

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: 04/28/2022
• Device Model Number: M0035423060
• Device Catalogue Number: M0035423060
• Device Lot Number: 21393858
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 11/16/2020
• 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: CARRY LEON MICROCATHETER (UNKNOWN MANUFACTURER); GUIDEWIRE (UNKNOWN MANUFACTURER); CARRY LEON MICROCATHETER (UNKNOWN MANUFACTURER); GUIDEWIRE (UNKNOWN MANUFACTURER)