MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 1.5MM X 2.0CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5411520
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure a microcatheter migrated from the target site, thus the subject coil was withdrawn from it.When the subject coil was reinserted into the microcatheter and brought to the target lesion it was discovered that the main coil was missing.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.B1 adverse event/product problem - corrected - no product problem.H1 type of reportable event - corrected - no malfunction.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 coil delivery wire was seen to be kinked/bent in multiple areas.The main coil was attached to the delivery wire.The main coil was seen to be stretched.The main coil suture was seen to be damaged.Functional inspection was not conducted as the reported event was not confirmed during the visual inspection as the main coil was returned attached to the delivery wire.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 not confirmed based on analysis.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 confirmed to be in good condition during preparation/prior to use on the patient and was prepared for use as per the directions for use, continuous flush was set up and maintained throughout the clinical procedure, the tapered distal end of the introducer sheath was firmly seated in the hub of the microcatheter, the rotating hemostatic valve (rhv) was adequately tightened while the introducer sheath was in the hub (not over/under-tightened) and was opened enough to allow passage of the device through without damage, no torque was given where advancing the delivery wire, the coil was advanced slowly and gently without applying excessive force, and there was no allegation against the microcatheter (unknown type).Based on the information provided in the complaint, the device appears to have been used as intended.The reported event was not confirmed during the visual inspection as the main coil was returned attached to the delivery wire.Therefore, not confirmed will be assigned to the reported event 'main coil prematurely detached/separated during use' since the issue included a returned product review (visual, physical, and/or performance testing) which showed no evidence of either the alleged issue or any defect which could have contributed to the event.An assignable cause of procedural factors will be assigned to the analyzed events 'main coil stretched' and 'main coil suture damage' 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 analyzed event 'coil delivery wire kinked/bent' since this issue is most likely due to handling of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that during the procedure a microcatheter migrated from the target site, thus the subject coil was withdrawn from it.When the subject coil was reinserted into the microcatheter and brought to the target lesion it was discovered that the main coil was missing.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET TETRA 1.5MM X 2.0CM
• 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: 20535568
• Report Number: 3008881809-2024-00507
• Device Sequence Number: 18259116
• Product Code: HCG
• UDI-Device Identifier: 07613327580099
• UDI-Public: (01)07613327580099(17)261028(10)24595898
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K222533
• 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): 01/07/2025

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 Catalogue Number: TG5411520
• Device Lot Number: 24595898
• 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: 10/04/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• 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: GUIDEWIRE (UNKNOWN); MICROCATHETER (UNKNOWN)
• Patient Sex: Unknown