MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 5MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035475200
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure upon inserting the 6th coil (subject device), the physician felt resistance and identified that the coil had detached within the microcatheter without the use of a power supply device.The physician proceeded to remove and exchange both the subject device and microcatheter.The procedure continued and completed without consequences to the patient.
Additional Manufacturer Narrative
The automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the subject device was noted that the main coil was not returned, it had been manually detached.The delivery wire was observed to be kinked; likely due to handling.It can be presumed that the delivery wire was damaged during the procedure as force may have been applied when the friction was felt.Functional tests were unable to carry out as main coil was detached and not returned.The events reported were partially confirmed based on the analysis of the returned device; however, analysis results are consistent with the 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.An assignable cause of procedural factors will be assigned to the reported event and as analyzed, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the device direction for use (dfu) but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that during the procedure upon inserting the 6th coil (subject device), the physician felt resistance and identified that the coil had detached within the microcatheter without the use of a power supply device.The physician proceeded to remove and exchange both the subject device and microcatheter.The procedure continued and completed without consequences to the patient.

• Brand Name: TARGET 360 SOFT 5MM X 20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9635294
• Report Number: 3008881809-2020-00021
• Device Sequence Number: 19499980
• Product Code: HCG
• UDI-Device Identifier: 04546540676511
• UDI-Public: 04546540676511
• Combination Product (Y/N): N
• 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): 04/04/2020

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 Expiration Date: 06/30/2020
• Device Model Number: M0035475200
• Device Catalogue Number: M0035475200
• Device Lot Number: 19920993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 03/29/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 04/04/2020
• 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: AXIUM; CHIKAI; EXCELSIOR 1018 MICROCATHETER (STRYKER); OPTIMO/7F; VORTX; AXIUM; CHIKAI; EXCELSIOR 1018 MICROCATHETER (STRYKER); OPTIMO/7F; VORTX
• Patient Age: 79 YR