MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035476200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during left ica (internal carotid artery) oa aneurysm embolization case when advancing the coil (subject device) into aneurysm, slight resistance was encountered inside the catheter.When the operator adjusting its position in aneurysm after filling, the distal end of the coil (subject device) delivery wire fractured.The operator withdrew the microcatheter and the delivery wire out together together with the fractured tip.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that during left ica (internal carotid artery) oa aneurysm embolization case when advancing the coil (subject device) into aneurysm, slight resistance was encountered inside the catheter.When the operator adjusting its position in aneurysm after filling, the distal end of the coil (subject device) delivery wire fractured.The operator withdrew the microcatheter and the delivery wire out together with the fractured tip.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 mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil delivery wire was found to be kinked/bent in multiply areas.There was no breakage of coil delivery wire noted.The main coil was found to be detached.The detachment seems to be mechanical.The main coil was found to be tangled.Coil in catheter friction functional test was unable to perform due to condition of the device.Coil delivery wire broken/fractured during use functional test was not confirmed during the visual 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.The reported coil in catheter friction could not be confirmed; however, the analysis results are consistent with the reported event.The reported coil delivery wire broken/fractured during use was not confirmed during the analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.During analysis, the main coil was found to be detached/separated from the coil delivery wire.The coil delivery wire was found to be kinked/bent.The main coil was found to be tangled.An assignable cause of not confirmed will be assigned to the as reported 'coil delivery wire broken/fractured during use' as the defect was not confirmed during the analysis.An assignable cause of procedural factors will be assigned to the as reported 'coil in catheter friction' and as analyzed 'main coil prematurely detached/separated during use', 'main coil tangled' as these defects appear to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.An assignable cause of handling damage will be assigned to the as analyzed 'coil delivery wire kinked/bent' as this issue is associated with handling of the device during the clinical procedure.

• Brand Name: TARGET 360 SOFT 6MM X 20CM
• 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: 16414986
• Report Number: 3008881809-2023-00080
• Device Sequence Number: 17508228
• Product Code: HCG
• UDI-Device Identifier: 04546540676542
• UDI-Public: 04546540676542
• 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): 03/24/2023

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: 10/16/2024
• Device Model Number: M0035476200
• Device Catalogue Number: M0035476200
• Device Lot Number: 23255004
• 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: 02/16/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• 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: 6F GUIDE CATHETER (STRYKER); GUIDEWIRE (STRYKER); HEADWAY17 CATHETER (NON-STRYKER); PRIME COIL (MEDTRONIC); TARGET COILS (STRYKER); WALLABY COIL (NON-STRYKER)
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Race: Asian