MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 3.5MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035443560
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not received for evaluation.
Event or Problem Description
It was reported that the subject coil (target) prematurely detached in the catheter during the procedure.The patients¿ medical condition was good.There were no adverse consequences reported to the patient.
Additional Manufacturer Narrative
D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.The device was returned within a dispenser coil in the introducer sheath.The lot number was not confirmed because the packaging was not returned with the device.During visual inspection, the proximal contact wire was intact.The coil delivery wire was kinked/bent.The main coil was manually detached and not returned.Functional testing was not required as the reported defect was confirmed during analysis.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 complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.In the case of this complaint, it is likely that the main coil was pushed/pulled against resistance during repositioning inside the microcatheter and the main coil prematurely separated as a result.An assignable cause of procedural factors will be assigned to the coil detaching/separating during use since this issue 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 and/or anatomical factors during use.An assignable cause of handling damage will be assigned to the coil delivery wire kinking since this issue is likely due to handling of the device during the clinical procedure.
Event or Problem Description
It was reported that the subject coil (target) prematurely detached in the catheter during the procedure.The patients¿ medical condition was good.There were no adverse consequences reported to the patient.

• Brand Name: TARGET 360 NANO 3.5MM X 6CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10347197
• Report Number: 3008881809-2020-00222
• Device Sequence Number: 3416852
• Product Code: HCG
• UDI-Device Identifier: 07613252600343
• UDI-Public: 07613252600343
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 09/30/2020

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: M0035443560
• Device Catalogue Number: M0035443560
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SL -10 CATHETER (STRYKER)