MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 8MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036180840
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure of spleen aneurysm coil embolization, when the subject coil was attempted to advanced into the microcatheter, there was resistance inside the microcatheter and it got detached prematurely.The prematurely detached subject coil was removed from the patient's vasculature by applying negative pressure with a syringe.The physician replaced the subject coil with a new device and same microcatheter was used to complete the procedure successfully.No clinical consequences were 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.Visual/microscopic inspection indicated that the delivery wire was not returned with the main coil.The main coil was found to be detached from the delivery wire.Functional inspection: coil in catheter friction functional test ¿ unable to perform the test as the main coil was found to be detached.Main coil prematurely detached/separated during use (outside patient) functional test - n/a.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 there was no damage noted to the packaging prior to opening, the device was confirmed to be in good condition during preparation/prior to use on the patient and it is unknown if continuous flush was set up and maintained during the clinical procedure but there were 9 other coils already successfully deployed before this (10th) coil displayed an issue.The tapered distal end of the introducer sheath was firmly seated in the hub of the microcatheter.Based on the investigation, this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.Therefore, an assignable cause of procedural factors will be assigned to the ar/aa code main coil prematurely detached/separated during use, and to the ar (as reported) codes coil in catheter friction as well as the aa (as assignable) codes main coil kinked/bent and main coil stretched.
Event or Problem Description
It was reported that during the procedure of spleen aneurysm coil embolization, when the subject coil was attempted to advanced into the microcatheter, there was resistance inside the microcatheter and it got detached prematurely.The prematurely detached subject coil was removed from the patient's vasculature by applying negative pressure with a syringe.The physician replaced the subject coil with a new device and same microcatheter was used to complete the procedure successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XXL 360 8MM 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: 11697789
• Report Number: 3008881809-2021-00167
• Device Sequence Number: 3481137
• Product Code: HCG
• UDI-Device Identifier: 07613327466423
• UDI-Public: 07613327466423
• 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): 07/01/2021

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: 01/07/2023
• Device Model Number: M0036180840
• Device Catalogue Number: M0036180840
• Device Lot Number: 22040431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 07/01/2021
• 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 1018 MICROCATHETER (STRYKER)