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	01/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure, the subject coil encountered difficulty while being pushed and pulled in the microcatheter and was found to have detached prematurely.The physician tried to remove the subject coil from the microcatheter, but it got stuck at the catheter tip.Physician removed the entire catheter and coil from the patient anatomy.Attempts to remove the subject coil from the catheter outside the patient¿s body were still unsuccessful.The procedure was completed with no clinical consequences reported to the patient due to this event.
Event or Problem Description
It was reported that during the procedure, the subject coil encountered difficulty while being pushed and pulled in the microcatheter and was found to have detached prematurely.The physician tried to remove the subject coil from the microcatheter, but it got stuck at the catheter tip.Physician removed the entire catheter and coil from the patient anatomy.Attempts to remove the subject coil from the catheter outside the patient¿s body were still unsuccessful.The procedure was completed with no clinical consequences 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.The device was returned within a non stryker catheter & wire.The lot number was not confirmed as the packaging was not returned with the device.During the visual inspection, the device was returned severely tangled around the non-stryker catheter.There was a large amount of blood present on the main coil itself.The catheter was soaked in warm water and the device attempted to be removed but due to the entanglement of the main coil this could not be completed.During functional testing, a 0.0158" mandrel was inserted through the proximal part of the non-stryker catheter without issue.The main coil was not detached/separated from the delivery wire, and was found to be still attached to the delivery wire.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 damage noted to the device would be indicative of the as reported defect.The device was returned severely tangled around the non-stryker catheter.The main coil was not detached/separated from the delivery wire, and was found to be still attached to the delivery wire.The as reported main coil prematurely detached/separated during use was not confirmed.As reported main coil friction and as reported/analyzed coil jammed 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.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: 11263666
• Report Number: 3008881809-2021-00058
• Device Sequence Number: 2590315
• Product Code: HCG
• UDI-Device Identifier: 04546540675941
• UDI-Public: 04546540675941
• 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): 05/11/2021

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: 08/06/2022
• Device Model Number: M0035424150
• Device Catalogue Number: M0035424150
• Device Lot Number: 21648506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 05/11/2021
• 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: VELOUTE MICROCATHETERASAHI