MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 5 MM X 10 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035475100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The subject device was returned for analysis and it was discovered that the coil (subject device) delivery wire was found to be broken/fracture during use.There were no clinical consequences to the patient reported as a result of 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.Visual inspection of the subject coil device revealed that the main coil was seen to be kinked/bent and stretched.The coil delivery wire was seen to be kinked/bent and broken.The introducer sheath was not returned.Functional testing was not performed as the proximal end of a delivery wire is missing.Although the functional testing was not performed and the coil detachment during analysis was not confirmed but the damage noted during analysis of the detached proximal contact is indicative of the reported detachment failure.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The analysis results are consistent with the reported event.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 was the coil could not be detached.It was reported that 5 attempts were made to detach the coil.It was also reported that the device was prepared as per the dfu, there was no damage noted to the proximal section of the delivery wire prior to inserting into the in-zone that there was no damage noted to the packaging prior to opening and the device was confirmed to be in good condition during preparation/prior to use on the patient, and that continuous flush was set up and maintained during the procedure.During analysis, the coil delivery wire was found to be kinked/bent and broken.The proximal end of the delivery wire was not returned.The coil was found to be stretched and kinked during device analysis.In the case of this complaint, it is likely that the delivery wire was damaged due to handling when inserting the device into the inzone detachment system.Therefore, the as analyzed ¿coil delivery wire kinked/bent and coil delivery wire broken/fractured during use¿ will be assigned handling damage as this complaint appears to be associated with handling of the product or portion of the product during the procedure.An assigned procedural factors will be assigned to as reported ¿main coil failed/unable to detach' as well as the as analyzed ¿main coil stretched and main coil kinked/bent ¿ as this complaint appears 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 factors during use.

• Brand Name: TARGET 360 SOFT 5 MM X 10 CM
• 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: 15947778
• Report Number: 3008881809-2022-00609
• Device Sequence Number: 12425950
• Product Code: HCG
• UDI-Device Identifier: 04546540676498
• UDI-Public: 04546540676498
• 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
• Report Date (Section B): 12/09/2022

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: 01/18/2025
• Device Model Number: M0035475100
• Device Catalogue Number: M0035475100
• Device Lot Number: 23421945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• 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
• Patient Age: 76 YR
• Patient Sex: Female