MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 3MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035443060
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
The subject device was returned for analysis and the device investigation revealed that the subject coil broke/fractured during use.No clinical consequences were reported to the patient due to 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.The device was returned and the lot number was confirmed from its packaging.During visual inspection, the main coil was found broken/fractured distal to the detachment zone.Functional testing was not performed due to the condition of the returned device.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 reported event of coil jammed could not be confirmed.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.During analysis it was confirmed that the main coil was fractured at the detachment zone.The main coil was not returned.Per the event description "the customer thinks a coil may have gotten stuck in the microcatheter." it is likely that the subject 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 jammed' as well as the as analyzed event of 'main coil broken/fractured during use' 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.

• Brand Name: TARGET 360 NANO 3MM X 6CM
• 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: 16030416
• Report Number: 3008881809-2022-00643
• Device Sequence Number: 5450135
• Product Code: HCG
• UDI-Device Identifier: 07613252600329
• UDI-Public: 07613252600329
• 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
• 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: 10/12/2023
• Device Model Number: M0035443060
• Device Catalogue Number: M0035443060
• Device Lot Number: 22484659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2020
• 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: ECHELON 10 MICROCATHETER (MEDTRONIC); INZONE DETACHMENT SYSTEM (STRYKER)
• Patient Sex: Unknown