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

Model Number	M0036126200
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
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 a coil embolization procedure was performed in internal iliac artery, in a patient.During the procedure the subject coil was pushed and pulled several times inside the lumen of the microcatheter and the subject coil was prematurely detached inside the microcatheter.The detached subject coil was removed out of the patient vascular anatomy and retrieved with a snare device.The procedure was completed and no clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual inspection: the main coil was returned detached from the coil delivery wire.The coil delivery wire was seen to be kinked.The main coil was seen to be stretched.The main coil was seen to be tangled.The main coil was seen to be kinked/bent.Functional inspection: not required.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 the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure.During analysis, the main coil was found to be kinked/bent, tangled and stretched.Based on analysis, it is possible that the coil may have been advanced against friction in the microcatheter during the procedure which in turn could cause damage to the coil and premature detachment when the device was retracted.An assignable cause of procedural factors will be assigned to the as reported (ar) / as analyzed (aa) 'main coil prematurely detached/separated during use' as well as the aa 'main coil stretched', 'main coil tangled' and' main coil kinked/bent' since these issues are 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' since this issue is due to handling of the product during the clinical procedure.
Event or Problem Description
It was reported that a coil embolization procedure was performed in internal iliac artery, in a patient.During the procedure the subject coil was pushed and pulled several times inside the lumen of the microcatheter and the subject coil was prematurely detached inside the microcatheter.The detached subject coil was removed out of the patient vascular anatomy and retrieved with a snare device.The procedure was completed and no clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XL 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: 13472300
• Report Number: 3008881809-2022-00050
• Device Sequence Number: 17350116
• Product Code: HCG
• UDI-Device Identifier: 07613327004625
• UDI-Public: 07613327004625
• 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): 04/27/2022

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: 04/03/2024
• Device Model Number: M0036126200
• Device Catalogue Number: M0036126200
• Device Lot Number: 22841350
• 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: 01/13/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2021
• 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: UNKNOWN MICROCATHETER; UNKNOWN SNARE DEVICE
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown