MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421540
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 1 of 2 report.The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure when the subject coil was used, the physician was able to pack and detach the subject coil at target location.However upon attempting to remove the catheter, the proximal tip of the subject coil was stuck near the catheter tip after its detachment.The physician used already existing guidewire to remove the subject coil from the catheter tip but couldn't get it out of the catheter.After multiple removal attempts the physician was successful in separating the subject coil from the catheter tip.Physician was able to complete the procedure successfully with no clinical consequences to the patient.
Event or Problem Description
It was reported that during the procedure when the subject coil was used, the physician was able to pack and detach the subject coil at target location.However upon attempting to remove the catheter, the proximal tip of the subject coil was stuck near the catheter tip after its detachment.The physician used already existing guidewire to remove the subject coil from the catheter tip but couldn't get it out of the catheter.After multiple removal attempts the physician was successful in separating the subject coil from the catheter tip.Physician was able to complete the procedure successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
Although the lot number was not provided, the automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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 preparation/set-up was performed as per the dfu, the event for both coils occurred during the same procedure, continuous flush was maintained for the duration of the procedure, the rhv was adequately tightened, no excessive force was applied at any point while advancing the coil, and there was no allegation against the microcatheter used in the case.It was also noted that the issue was observed when using a guidewire to remove the catheter as the guidewire could not exit the catheter due to the jamming at the tip.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 and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.

• Brand Name: TARGET 360 NANO 1.5MM X 4CM
• 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: 11334982
• Report Number: 3008881809-2021-00083
• Device Sequence Number: 16990130
• Product Code: HCG
• UDI-Device Identifier: 04546540697998
• UDI-Public: 04546540697998
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 04/07/2021

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 Model Number: M0035421540
• Device Catalogue Number: M0035421540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 04/07/2021
• 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); NEUROFORM ATLAS STENT 3MM X 21MM (STRYKER); SYNCHRO 14 (STRKYER); TARGET DETACHABLE COIL 1MM X 3CM (STRYKER)