MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035424100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during a right vertebral artery (va) v5 dissection aneurysm procedure the operator used a guidewire to bring a microcatheter into the aneurysm.The aneurysm was framed with a coil and a stent was deployed through the microcatheter.After delivering three coils, the physician delivered the subject coil as the fourth coil but it was found that the tail of the delivery wire was fractured.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the distal part of the coil delivery wire was found to be broken/fractured.The main coil was found to be intact.The coil introducer sheath was found to be intact.Functional inspection was not performed as the ¿coil delivery wire broken/fractured during use¿ was confirmed during visual inspection.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 was confirmed based on analysis of the returned device.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use.There was no damage noted to the packaging prior to opening the packaging and the device was confirmed to be in good condition during preparation/prior to use on the patient.The continuous flush was set up and maintained throughout the clinical procedure.On visual inspection the distal part of the coil delivery wire was found to be broken/fractured.The main coil and coil introducer sheath was found to be intact.The reported event was confirmed during analysis.This complaint appears to be 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 factors during use.
Event or Problem Description
It was reported that during a right vertebral artery (va) v5 dissection aneurysm procedure the operator used a guidewire to bring a microcatheter into the aneurysm.The aneurysm was framed with a coil and a stent was deployed through the microcatheter.After delivering three coils, the physician delivered the subject coil as the fourth coil but it was found that the tail of the delivery wire was fractured.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET 360 ULTRA 4MM 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: 16944258
• Report Number: 3008881809-2023-00254
• Device Sequence Number: 19380365
• Product Code: HCG
• UDI-Device Identifier: 07613252192336
• UDI-Public: 07613252192336
• 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): 07/17/2023

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: 04/12/2025
• Device Model Number: M0035424100
• Device Catalogue Number: M0035424100
• Device Lot Number: 23589153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2022
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER); NEUROFORM ATLAS STENT (STRYKER); SYNCHRO GUIDEWIRE (STRYKER); TARGET COIL (STRYKER)
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Race: Asian