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

Model Number	M0035442040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure, when the physician tried to insert the subject coil into the aneurysm, it got stretched and it was removed using a snare device.No excessive force was applied.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added d4 expiration date - added due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The product was not returned for analysis.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 there was no damage noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition during preparation/prior to use on the patient and the device was prepared for use as per the directions for use.Continuous flush was set up and maintained throughout the clinical procedure.The dw and the introducer sheath were taken out together from the dispenser hoop and there was no resistance experienced when the coil was taken out of dispenser hoop.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, there was no friction or resistance while the coil was advancing the introducer sheath but it is unknown if friction or resistance was felt at the hub, the coil was advanced slowly and gently and excessive force was not applied while advancing the coil and no torque was given when advancing the dw.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned for the reported issue ¿main coil stretched'.A medical intervention was required to remove the stretched coil using a snare device therefore an assignable cause of procedural factors will be assigned to the reported and ¿patient medical or surgical intervention required¿ as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that during the procedure, when the physician tried to insert the subject coil into the aneurysm, it got stretched and it was removed using a snare device.No excessive force was applied.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• 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: 12229881
• Report Number: 3008881809-2021-00314
• Device Sequence Number: 11884784
• 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,Followup
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/21/2022
• Device Model Number: M0035442040
• Device Catalogue Number: M0035442040
• Device Lot Number: 21839087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2019
• 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: GOOSENECK SNARE (UNKNOWN); GOOSENECK SNARE (UNKNOWN)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Race: Asian