MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 4MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035434080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an aca (anterior cerebral artery) aneurysm case.After inserting three coils, the operator delivered the fourth subject coil and distal of the subject coil got stuck in microcatheter.When the operator manipulate the subject coil from proximal, the reaction from distal became weaker.Continued to fill and after distal of the subject coil went into aneurysm, the operator found the distal could not follow the proximal manipulation.Withdrew the delivery wire slightly and found the subject coil fractured at the segment that is not the detachment zone.The operator used guidewire as a medical intervention to push the residual of the subject coil to go into aneurysm inside the microcatheter to finish.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.The patient is already wake up.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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 , the device was prepared for use as per the dfu.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.Continuous flush was set up and maintained throughout the clinical procedure.The coil got stuck within the micro catheter and when the physician withdrew the delivery wire slightly he found the coil fractured at the segment that is not the detachment zone.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 and the device was not returned, an assignable cause of undeterminable was assigned.
Event or Problem Description
It was reported that during an aca (anterior cerebral artery) aneurysm case.After inserting three coils, the operator delivered the fourth subject coil and distal of the subject coil got stuck in microcatheter.When the operator manipulate the subject coil from proximal, the reaction from distal became weaker.Continued to fill and after distal of the subject coil went into aneurysm, the operator found the distal could not follow the proximal manipulation.Withdrew the delivery wire slightly and found the subject coil fractured at the segment that is not the detachment zone.The operator used guidewire as a medical intervention to push the residual of the subject coil to go into aneurysm inside the microcatheter to finish.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.The patient is already wake up.

• Brand Name: TARGET HELICAL ULTRA 4MM X 8CM
• 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: 17557448
• Report Number: 3008881809-2023-00419
• Device Sequence Number: 3639744
• Product Code: HCG
• UDI-Device Identifier: 04546540676115
• UDI-Public: 04546540676115
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/20/2023

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: 03/22/2025
• Device Catalogue Number: M0035434080
• Device Lot Number: 23544198
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2022
• 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: COILS (UNKNOWN).; SYNCHRO GUIDEWIRE (STRYKER).; XT 17 CATHETER (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Race: Asian