MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035421530
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The coil (subject device) was returned for analysis and it was discovered that the coil (subject device) delivery wire was broken/fractured during use.The procedure was completed successfully.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 main coil was seen to be kinked/bent, the coil delivery wire was seen to be kinked/bent, and the coil delivery wire was seen to be broken/fractured.A functional inspection was not carried out due to the damage 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.The reported events could not be replicated during device analysis; 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.Additional information provided by the customer indicated that continuous flush set up and maintained throughout the procedure.No damage was noted to the packaging prior to opening, the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu.The device was returned for analysis and coil delivery wire was seen to be kinked/bent, the main coil was seen to be kinked and the coil delivery wire was seen to be broken/fractured.An assignable cause of not confirmed will be assigned to the as reported 'main coil failed/unable to detach' and 'coil proximal contact wire broken/ fractured' as the issue included a returned product review (visual, physical, and/or performance testing) which showed no evidence of either the alleged issue(s) or any defect which could have contributed to the event.The as analyzed codes, 'main coil kinked/bent' and 'coil delivery wire broken/fractured during use', will be assigned procedural factors 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 performance was limited due to procedural or anatomical factors during use.It is probable that the damage noted was sustained due to handling of the device during the clinical procedure therefore an assignable cause of handling damage will be assigned to the as analyzed 'coil delivery wire kinked/bent'.

• Brand Name: TARGET 360 NANO 1.5MM X 3CM
• 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: 17667487
• Report Number: 3008881809-2023-00446
• Device Sequence Number: 7124230
• Product Code: HCG
• UDI-Device Identifier: 04546540697943
• UDI-Public: 04546540697943
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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
• Report Date (Section B): 08/31/2023

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: 08/07/2026
• Device Catalogue Number: M0035421530
• Device Lot Number: 24167456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2023
• 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: INZONE DETACHMENT SYSTEM (STRYKER); SL-10 CATHETER (STRYKER)
• Patient Sex: Unknown