MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 13MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035471330
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during procedure the coil(subject device) could not be advanced further during coiling and it was found that coil delivery wire was broken/fracture during use.There was a surgical delay of 5 minutes.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
C2/d10: concomitant products grid-updated.H4: manufacturing date ¿ added.H3: device evaluated by mfg ¿updated.H3: summary attached - updated.D4: expiration date - added.D9: product available to stryker ¿ updated.D9: returned to manufacturer on ¿updated.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 event ¿coil delivery wire broken/fractured during use¿ was not confirmed during analysis.The reported ¿main coil friction¿ was confirmed during then analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The device was analyzed.The delivery wire was found to be kinked/bent.No breakage noted.The main coil was found to be broken fractured, stretched and kinked/bent.The coil stuck inside the microcatheter and could not be removed due to significant friction.An assignable code as ¿not confirmed¿ will be assigned to the as reported ¿coil delivery wire broken/fractured during use¿ as the defect was not confirmed during the analysis.An assignable cause of procedural factors will be assigned to the as reported/as analyzed ¿main coil friction¿, and as analyzed ¿main coil broken/fractured¿, ¿main coil stretched¿, ¿main coil kinked/bent¿ as the defects are 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 and/or anatomical factors during use.An assignable cause of handling damage will be assigned to the as analyzed 'coil delivery wire kinked/bent' since it is most likely that this damage occurred due to handling of delivery wire during the clinical procedure.
Event or Problem Description
It was reported that during procedure the coil (subject device) could not be advanced further during coiling and it was found that coil delivery wire was broken/fracture during use.There was a surgical delay of 5 minutes.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET 360 SOFT 13MM X 30CM
• 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: 15172211
• Report Number: 3008881809-2022-00384
• Device Sequence Number: 6330384
• Product Code: HCG
• UDI-Device Identifier: 07613252192688
• UDI-Public: 07613252192688
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/24/2022

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: 03/08/2024
• Device Model Number: M0035471330
• Device Catalogue Number: M0035471330
• Device Lot Number: 22783869
• 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: 07/27/2022
• Supplement Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2021
• 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: ECHELON CATHETER(NON STRYKER).; ECHELON MICROCATHETER(NON-STRYKER).
• Patient Sex: Unknown