MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035476200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure the coil was broken/fractured prior to deploying.No other information is available at this time.
Event or Problem Description
It was reported that during the procedure the coil was broken/fractured prior to deploying.No other information is available at this time.
Additional Manufacturer Narrative
The device was returned and the reported lot number was not confirmed as the packaging was not returned with the device.During visual inspection, the coil delivery wire and the proximal contact were seen to be kinked.The main coil was seen to have no break/fractures and was severely stretched.The device was returned without the sutra present.Functional inspection was not carried out due to the condition of the returned coil.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 main coil fracture was not confirmed during the device analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that the 'coil snapped prior to deploying'.There was no additional information available.The device was returned and there was no break/fracture noted to the coil, however there was significant stretching noted to the coil with damage to the suture, which may have been perceived as a fracture.An assignable cause of not confirmed will be assigned to the reported event of the main coil broken/fractured during use.The delivery wire and proximal contact were kinked.It is probable that the main coil was stretched and the suture was damaged in the attempt to position the coil prior to deployment, therefore an assignable cause of procedural factors will be assigned to the analyzed defect of the main coil stretched and main coil suture damage.It is probable that the delivery wire and proximal contact were kinked as a result of handling of the device during the clinical procedure, therefore an assignable cause of handling damage will be assigned to the analysed defect of the coil delivery wire kinked/bent, and the coil proximal contact kinked/bent.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: TARGET 360 SOFT 6MM X 20CM
• 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: 12641596
• Report Number: 3008881809-2021-00439
• Device Sequence Number: 1205472
• Product Code: HCG
• UDI-Device Identifier: 04546540676542
• UDI-Public: 04546540676542
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 02/22/2022

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 Model Number: M0035476200
• Device Catalogue Number: M0035476200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown