MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, one of the seven coils broke and got stuck within the lumen of the microcatheter which did not allow other coils to be deployed.The detachment system was also reported to have stopped during the case.The broken subject coil along with the microcatheter was removed and replaced.The procedure was completed successfully and no clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during the procedure, one of the seven coils broke and got stuck within the lumen of the microcatheter which did not allow other coils to be deployed.The detachment system was also reported to have stopped during the case.The broken subject coil along with the microcatheter was removed and replaced.The procedure was completed successfully and no clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
B1: adverse event/product problem ¿ corrected - no ¿product problem¿.H1: type of reportable event ¿ corrected - no ¿malfunction¿.H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.The returned product was confirmed to be the product reported in the complaint.During visual inspection, the main coil found to be kinked/bent.During functional inspection, the main coil could not be advanced from the introducer sheath.Due to the automated manufacturing execution system system there are controls in the manufacturing process to ensure the product met specifications upon release.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 device was returned for analysis and the reported event of main coil broken/fractured during use was not confirmed.The reported event of coil in catheter friction was not confirmed but the noted sheath friction during analysis is indicative of the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.During analysis of the concurrent complaint addressing one of the coils used in conjunction with the subject coil in the procedure, it was confirmed that the other main coil was fractured at the detachment zone which was not returned.Per the event description "the customer thinks a coil may have gotten stuck in the microcatheter." it is likely that the other coil detached inside the microcatheter which resulted in subsequent coils not being able to advance through the microcatheter.An assignable cause of procedural factors will be assigned to the as reported event of coil in catheter friction, as well as the as analyzed events of main coil kinked/bent and coil introducer sheath friction since these defects 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 not confirmed will be assigned to the as reported event of main coil broken/fractured during use.The issue included a returned product review (visual, physical, and performance testing) which showed no evidence of the alleged issue(s).The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: TARGET 360 NANO 1.5MM 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: 15581088
• Report Number: 3008881809-2022-00503
• Device Sequence Number: 12348534
• Product Code: HCG
• UDI-Device Identifier: 04546540697998
• UDI-Public: 04546540697998
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 12/21/2022

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: 04/04/2025
• Device Model Number: M0035421540
• Device Catalogue Number: M0035421540
• Device Lot Number: 23576672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2022
• 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: ECHELON 10 MICROCATHETER (MEDTRONIC); INZONE DETACHMENT SYSTEM (STRYKER)
• Patient Sex: Unknown