MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035425150
Medical Device Problem Codes	Fracture (1260); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure in case of ic-pc cerebral aneurysm embolization for sah, the coil (subject device) encountered resistance at the distal of the microcatheter that it was difficult to place.The coil (subject device) was prematurely detached when it was tried to be retrieved.The prematurely detached coil (subject device) was removed by using the snare, and successfully retrieved.The procedure was completed successfully without re-embolization.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during procedure in case of ic-pc cerebral aneurysm embolization for sah, the coil (subject device) encountered resistance at the distal of the microcatheter that it was difficult to place.The coil (subject device) was prematurely detached when it was tried to be retrieved.The prematurely detached coil (subject device) was removed by using the snare, and successfully retrieved.The procedure was completed successfully without re-embolization.No clinical consequences were reported to the patient due to this event.
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 device was returned together with microcatheter and snare device, the coil delivery wire was found to be kinked/bent, the main coil was found to be stretched and kinked bent, the suture was found to be damaged, the main coil was found to be broken/fractured, no detachment at the detachment zone noted and significant amount of blood noted during the analysis.During functional inspection, coil in catheter friction functional test was unable to perform due to condition of the device.Main coil prematurely detached/separated during use functional ¿ detachment not confirmed during visual inspection.The reported 'main coil prematurely detached/separated during use' was not confirmed during the analysis.The reported 'coil in catheter friction' could not be confirmed; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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, the tortuosity of the patient's anatomy was normal, the tapered distal end of the introducer sheath was firmly seated in the hub of the microcatheter, the 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 the same microcatheter (excelsior sl-10 90°) was used to finish the procedure.The device was returned together with a microcatheter and snare device.Analysis of the returned device revealed the coil delivery wire was kinked/bent, the suture was damaged, and the main coil was kinked/bent and stretched.The main coil was also found to be broken/fractured and there was no detachment at the detachment zone.Therefore, the as reported 'main coil prematurely detached/separated during use' was not confirmed.It is probable that in the case of this complaint, the broken coil was interpreted as being prematurely detached.The damage to the main coil likely occurred due to procedural factors during manipulation of the device against the reported friction.Therefore, an assignable cause of procedural factors will be assigned to the as reported 'coil in catheter friction' and the as analyzed 'main coil kinked/bent', 'main coil stretched', 'main coil broken/fractured during use' and 'main coil suture damage'.An assignable cause of handling damage will be assigned to the analyzed 'coil delivery wire kinked/bent' since this damage likely occurred due to handling of this portion of the device during the clinical procedure.

• Brand Name: TARGET 360 ULTRA 5MM X 15CM
• 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: 13085563
• Report Number: 3008881809-2021-00551
• Device Sequence Number: 14808156
• Product Code: HCG
• UDI-Device Identifier: 04546540675965
• UDI-Public: 04546540675965
• 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): 04/02/2022

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: 05/28/2022
• Device Model Number: M0035425150
• Device Catalogue Number: M0035425150
• Device Lot Number: 21477168
• 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: 12/19/2021
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 12/25/2021
• Supplement Report FDA Received Date: 04/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2019
• 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 (STRYKER MANUFACTURER); TARGET 360 SOFT 6×10 (STRYKER MANUFACTURER); TARGET 360 SOFT 7×20 (STRYKER MANUFACTURER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female