MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 7MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035477150
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 device was returned, and the lot number was confirmed with the packaging returned with the device.During visual inspection, the subject coil was retuned tangled with a retriever.The coil delivery wire was found to be kinked/bent.The coil delivery wire was seen to be broken/ fractured.The main coil was found to be stretched.Functional inspection was unable to be performed due to damage.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 reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Based on the information provided the main coil was stuck in the microcatheter.Other coils had been delivered prior to this event.It is likely that the pi (polyimide) wire (delivery wire component) broke in attempt to advance the coil against resistance and a retriever had to be used to remove the coil.An assignable cause of procedural factors will be assigned to the as reported events of coil in catheter friction, main coil prematurely detached/separated during use and the as analyzed events of coil delivery wire broken/fractured 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 accordance with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.An assignable cause of handling damage will be assigned to the as analyzed event of coil delivery wire kinked/bent as the issue is due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.
Event or Problem Description
It was reported that during the procedure, resistance was encountered when inserting the subject coil through the microcatheter.Additional information was received on 14 nov 2024, that a retriever was required to remove the coil from the microcatheter as a medical intervention.Additional information was received on 26 nov 2024 that the coil had prematurely detached during use.

• Brand Name: TARGET 360 SOFT 7MM X 15CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 20861716
• Report Number: 3008881809-2024-00578
• Device Sequence Number: 19841668
• Product Code: HCG
• UDI-Device Identifier: 04546540676566
• UDI-Public: (01)04546540676566(17)270314(10)24858816
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K120850
• 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
• Report Date (Section B): 12/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M0035477150
• Device Lot Number: 24858816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR SL 10 MICROCATHETER (STRYKER); TREVO RETRIEVER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female