MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 16MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036121650
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during the procedure the subject coil prematurely detached from the pusher wire inside the catheter.The coil was removed from the catheter with a micro snare.There was a surgical delay of unknown time.The patient was not affected.The device was replaced and the procedure was completed successfully.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated.Due to the automated (manufacturing execution system) mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the device was returned with microcatheter.The coil delivery wire was seen to be kinked/bent.The main coil was found to be kinked/bent.The main coil was found to be detached/separated from the delivery wire.Functional inspection was not performed as the damage was confirmed during visual inspection.The reported event is covered in the device direction 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 device analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that the coil prematurely separated from the delivery wire inside an microcatheter.A snare was subsequently used to remove the coil.No further details of the event were provided.Based on the device analysis it was confirmed that the coil detached due to a physical break of the delivery wire (pi wire).An assignable cause of procedural factors will be assigned to the reported and analyzed event of the main coil prematurely detached/separated during use and main coil kinked/bent.The issue appears to be 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 analyzed damage of the 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 during the procedure the subject coil prematurely detached from the pusher wire inside the catheter.The coil was removed from the catheter with a micro snare.There was a surgical delay of unknown time.The patient was not affected.The device was replaced and the procedure was completed successfully.

• Brand Name: TARGET XL 360 SOFT 16MM X 50CM
• 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: 20623649
• Report Number: 3008881809-2024-00533
• Device Sequence Number: 8821028
• Product Code: HCG
• UDI-Device Identifier: 04546540711557
• UDI-Public: (01)04546540711557(17)241026(10)23236306
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K123377
• 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): 12/26/2024

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 Expiration Date: 10/26/2024
• Device Catalogue Number: M0036121650
• Device Lot Number: 23236306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2021
• 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: AXS CATALYST 5 CATHETER (STRYKER).; MICRO SNARE (UNKNOWN).; SL-10 CATHETER (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown