MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 3MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035433100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available.
Event or Problem Description
It was reported that during a coiling procedure in acom (anterior communicating artery), the physician attempted to deploy third coil (subject device), but the microcatheter kept kicking out of the aneurysm.The physician manipulated the catheter to try and get the coil (subject device) to sit in the aneurysm.But the microcatheter kicked fully out and while trying to pull the coil (subject device) back into the microcatheter the coil (subject device) got hung up on the stent.The physician had to pull with force to remove the coil (subject device) and the coil (subject device) separated from the delivery wire.The physician then successfully removed the coil (subject device) with a snare, and did follow up imaging confirming that there was no harm done to the patient.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional inspections were not performed due to the product was not returned.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 complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Additional information provided by the customer indicated that no anomalies were noted to the device prior to use, the device was prepared as per the dfu, and continuous flush was maintained for the duration of the procedure.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned for analysis, an assignable cause of undeterminable was assigned to this complaint.
Event or Problem Description
It was reported that during a coiling procedure in acom (anterior communicating artery), the physician attempted to deploy third coil (subject device), but the microcatheter kept kicking out of the aneurysm.The physician manipulated the catheter to try and get the coil (subject device) to sit in the aneurysm.But the microcatheter kicked fully out and while trying to pull the coil (subject device) back into the microcatheter the coil (subject device) got hung up on the stent.The physician had to pull with force to remove the coil (subject device) and the coil (subject device) separated from the delivery wire.The physician then successfully removed the coil (subject device) with a snare, and did follow up imaging confirming that there was no harm done to the patient.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET HELICAL ULTRA 3MM X 10CM
• 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: 16550212
• Report Number: 3008881809-2023-00130
• Device Sequence Number: 6042910
• Product Code: HCG
• UDI-Device Identifier: 04546540676092
• UDI-Public: 04546540676092
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/09/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2025
• Device Model Number: M0035433100
• Device Catalogue Number: M0035433100
• Device Lot Number: 23726180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2022
• 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: HEADWAY DUO MICROCATHETER (NON-STRYKER); NEUROFORM ATLAS STENT (STRYKER); NEURON MAX CATHETER (NON-STRYKER); SHORT SHEATH (NON-STRYKER); SOPHIA EX CATHETER (NON-STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown