MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035424150
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Analysis of the returned device found the main coil prematurely detached inside the microcatheter.There were no clinical consequences to the patient reported as a result of 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.During the visual inspection, the target coil was found inside the microcatheter and it was stuck at the tip of the microcatheter.There was second coil found inside the catheter and the main coil was found to be detached/separated.The main coil was found to be stretched and kinked/bent.The coil delivery wire was not retuned for analysis.Functional testing not needed as the reported issue was confirmed during the visual inspection.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 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, 5 coils were previously deployed using the returned sl-10 microcatheter, and there was no allegation against the microcatheter.The subject coil was found to be stuck at the tip of the microcatheter during analysis.The main coil was noted to be stretched, kinked and was detached/separated.There was a second coil also found inside the microcatheter.Based on the information provided, it is most likely that the second coil was one of the five coils previously deployed during the case.It is possible that this coil did not completely detach during the procedure and got stuck at the distal tip of the microcatheter when the delivery wire was withdrawn.As a result, this led to the reported jamming when the subject coil was advanced through the sl-10.Caused by other will be assigned to the as reported (ar) / as analyzed (aa) 'coil jammed' and as analyzed 'device interaction with another device' since the investigation indicates another product caused the issue.An assignable cause of procedural factors will be assigned to the as analyzed 'main coil stretched', 'main coil kinked/bent' and 'main coil prematurely detached/separated during use' as these defects appear 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.

• Brand Name: TARGET 360 ULTRA 4MM 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: 14317882
• Report Number: 3008881809-2022-00208
• Device Sequence Number: 4661086
• Product Code: HCG
• UDI-Device Identifier: 04546540675941
• UDI-Public: 04546540675941
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 05/06/2022

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: 03/14/2024
• Device Model Number: M0035424150
• Device Catalogue Number: M0035424150
• Device Lot Number: 22801895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2021
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Sex: Unknown