MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035442040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2021
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 the visual inspection, the main coil was found to be jammed in the returned microcatheter.The returned microcatheter was found to be intact.The main coil was found to be kinked/bent and stretched.The suture was found to be intact.The significant amount of dry blood and surgical fluids was noted during the analysis.During the functional inspection, main coil failed/unable to detach functional test was not able to be performed as the main coil was found to be detached.Coil in catheter friction functional test ¿ unable to perform the test as the main coil was found to be detached and jammed inside the catheter.The coil was removed from the microcatheter for further tests.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 tortuosity of the patient's anatomy was average, the tapered distal end of the introducer sheath was firmly seated in the hub of the microcatheter, the rhv was opened enough to allow passage of the device through without damage, no torque was given where advancing the delivery wire, and the coil was advanced slowly and gently without applying excessive force.During analysis, the subject coil was found to be jammed in the returned microcatheter and was prematurely detached at the detachment zone (no delivery wire returned).Therefore, the as reported 'main coil failed/unable to detach' was not confirmed.The main coil was found to be kinked/bent and stretched with the suture intact.There was a significant amount of dried blood and procedural fluids noted during analysis which may have indicated that continuous flush was not maintained.However, this could not be definitively determined.Based on visual inspection, it is probable that the main coil sustained damage during advancement/retraction inside the microcatheter which caused it to jam at the tip of the microcatheter.It then likely detached prematurely when the delivery wire was pulled back.An assignable cause of procedural factors will be assigned to the as analyzed 'main coil kinked/bent', ' main coil stretched', 'main coil prematurely detached/separated during use', 'coil jammed', and as reported 'coil in catheter friction' 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.
Event or Problem Description
Analysis of the returned device found that the subject coil was prematurely deployed during use.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: TARGET 360 NANO 2MM X 4CM
• 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: 12793204
• Report Number: 3008881809-2021-00477
• Device Sequence Number: 5657248
• Product Code: HCG
• UDI-Device Identifier: 07613252600299
• UDI-Public: 07613252600299
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/11/2021

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: 07/19/2023
• Device Model Number: M0035442040
• Device Catalogue Number: M0035442040
• Device Lot Number: 22340800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2020
• 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: CHIKAI 14 GUIDEWIRE (ASAHI INTECC MEDICAL); CHIKAI BLACK GUIDEWIRE (ASAHI INTECC MEDICAL); EXCELSIOR SL-10 MICROCATHETER (STRYKER); INZONE DATACHMENT SYSTEM (STRYKER); TRANSFORM BALLOON CATHETER (STRYKER)
• Patient Sex: Unknown
• Patient Race: Asian