MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 4.5MM X 12CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035474510
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a.Com (anterior communicating artery) aneurysm endovascular coil embolization procedure in the patient with multi-vessel disease, while advancement of the subject coil into the microcatheter it showed resistance for further continuous introduction of the coil inside aneurysm.So the operator tried to withdraw the coil which got stuck into the microcatheter and detached prematurely without any detachment attempt with detachment system.Therefore operator withdrew the microcatheter from patient vasculature with the prematurely detached coil in it.The procedure was completed successfully after smooth deployment of the two coils into the target aneurysm using same microcatheter.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 found to be kinked/bent.The delivery wire proximal contact was found to be intact.The main coil was found to be detached from the delivery wire.The main coil was found to be severely stretched.The main coil suture was found to be damaged.Functional inspection: main coil prematurely detached/separated inside patient functional test ¿ not applicable.Coil in catheter friction functional test ¿ unable to perform as the main coil was found to be detached.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 the procedure, the subject coil prematurely detached inside the microcatheter.Additional information provided by the customer indicated that the patients anatomy was tortuous, the device prepared as per the dfu.The device was returned and the main coil had been detached from the delivery wire, the main coil had been stretched and the suture damaged, the delivery wire was also kinked.It is probable that the main coil was stretched and detached within the microcatheter due to procedural or anatomical factors during use.An assignable cause of procedural factors will be assigned to the reported coil in catheter friction and main coil prematurely detached/separated during use and to the analyzed coil delivery wire kinked/bent, main coil suture damage, main coil prematurely detached/separated during use and main coil stretched, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that during a.Com (anterior communicating artery) aneurysm endovascular coil embolization procedure in the patient with multi-vessel disease, while advancement of the subject coil into the microcatheter it showed resistance for further continuous introduction of the coil inside aneurysm.So the operator tried to withdraw the coil which got stuck into the microcatheter and detached prematurely without any detachment attempt with detachment system.Therefore operator withdrew the microcatheter from patient vasculature with the prematurely detached coil in it.The procedure was completed successfully after smooth deployment of the two coils into the target aneurysm using same microcatheter.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 SOFT 4.5MM X 12CM
• 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: 11697876
• Report Number: 3008881809-2021-00168
• Device Sequence Number: 3481138
• Product Code: HCG
• UDI-Device Identifier: 04546540714787
• UDI-Public: 04546540714787
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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): 07/14/2021

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: 03/10/2023
• Device Model Number: M0035474510
• Device Catalogue Number: M0035474510
• Device Lot Number: 22190660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 07/14/2021
• 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: SL-10 MICRO CATHETER (STRYKER)