MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 9MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035479300
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
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 visual inspection, the coil delivery wire was found kinked/bent.The main coil was found detached/separated from the delivery wire, kinked/bent and stretched.The detachment seems to be mechanical.Functional testing was not performed as the coil was found to be detached/separated from the coil delivery wire.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, the patient's anatomy was not tortuous, an sl-10 microcatheter was used with the subject coil, the tapered distal end of the introducer sheath was firmly seated in the hub of the microcatheter (with a slight buckling or reactive force indicating proper positioning), the rhv was adequately tightened while the introducer sheath was in the hub (not over/under-tightened) and was opened enough to allow passage of the device through without damage, and the coil was advanced with a gentle push.The same microcatheter was used to finish the procedure and there was no allegation against the microcatheter.Analysis of the returned device revealed the main coil was detached/separated from the delivery wire.Based on visual inspection of the detachment zone, the main coil appeared to have been mechanically detached.The main coil was found to be kinked/bent and stretched and the coil delivery wire was found to be kinked/bent.In the case of this complaint, it is probable that the main coil encountered resistance in the microcatheter during the procedure which caused it to kink and stretch during manipulation.As a result, the main coil likely detached/separated from the delivery wire when force was applied to pull it back.An assignable cause of procedural factors was assigned to the as reported event "coil in catheter friction" and as analyzed events "main coil kinked/bent", "main coil stretched" and "main coil prematurely detached/separated" during use since these issues are 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.An assignable cause of handling damage was assigned to the as analyzed event "coil delivery wire kinked/bent" since this 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
Analysis of the returned device found that the subject coil prematurely detached/separated during use.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: TARGET 360 SOFT 9MM X 30CM
• 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: 13395415
• Report Number: 3008881809-2022-00043
• Device Sequence Number: 11786490
• Product Code: HCG
• UDI-Device Identifier: 04546540676627
• UDI-Public: 04546540676627
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 01/31/2022

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: 02/23/2023
• Device Model Number: M0035479300
• Device Catalogue Number: M0035479300
• Device Lot Number: 22159250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2020
• 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: INFINITY LONG SHEATH (STRYKER); SL-10 MICRO CATHETER (STRYKER)
• Patient Age: 50 YR
• Patient Sex: Male