MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036181040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that during a procedure for portal vein embolism, the subject coil was used.During the subject coil placement, there was friction at the distal microcatheter shaft and the subject coil was taken in and out several times for repositioning within the aneurysm, but it prematurely detached even though there was no attempt to detach with a detachment system.The subject coil was collected together with the microcatheter.The same microcatheter was then reinserted and another replacement coil was inserted successfully.The procedure was completed with no clinical consequences to the patient.
Event or Problem Description
It was reported that during a procedure for portal vein embolism, the subject coil was used.During the subject coil placement, there was friction at the distal microcatheter shaft and the subject coil was taken in and out several times for repositioning within the aneurysm, but it prematurely detached even though there was no attempt to detach with a detachment system.The subject coil was collected together with the microcatheter.The same microcatheter was then reinserted and another replacement coil was inserted successfully.The procedure was completed with no clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.Due to the automated manufacturing execution system (mes) system there are 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.It was reported that during coil placement, the subject coil was taken in and out several times for repositioning within the aneurysm, but the coil was prematurely detached.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the tapered distal end of the introducer sheath was firmly seated in the hub of the microcatheter, the rotating hemostatic valve (rhv) was opened enough to allow passage of the device through without damage, no excessive force was applied while advancing the coil, and no torque was given where advancing the delivery wire.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 XXL 360 10MM X 40CM
• 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: 11704651
• Report Number: 3008881809-2021-00174
• Device Sequence Number: 11844901
• Product Code: HCG
• UDI-Device Identifier: 07613327128406
• UDI-Public: 07613327128406
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161429
• 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): 07/19/2021

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: 09/13/2023
• Device Model Number: M0036181040
• Device Catalogue Number: M0036181040
• Device Lot Number: 22445641
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 07/20/2021
• 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: MICRO CATHETER (UNKNOWN); MICRO CATHETER (UNKNOWN)