MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 7MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035477300
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2020
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 the procedure the physician was unable to advance the coil into the aneurysm.So he decide to withdrew the subject coil and while doing so it detached prematurely inside the micro catheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned.The lot number was not confirmed as the packaging was not returned with the device.On visual inspection, the main coil was manually detached.The proximal contact wire was kinked/bent.The coil delivery wire was kinked/bent.The distal tip was found to be intact.The main coil was stretched.Functional test couldn't be performed as the main coil was detached.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 indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was maintained throughout the clinical procedure, an echelon-10 micro catheter was used, and the coil was advanced with force.During analysis, the coil proximal contact and delivery wire were found to be kinked and the main coil had been separated from the wire.The main coil was found to be stretched.Therefore, the reported event was confirmed.Based on visual inspection, it appears the coil had been manually detached.In the case of this complaint, it is most likely that the main coil stretched when it was manipulated against friction in the micro catheter.Due to the friction, it is probable that additional force was required to overcome the resistance causing the coil to prematurely separate in the catheter.An assignable cause of procedural factors will be assigned to the as reported and as analyzed, main coil prematurely detached/separated during use, coil in catheter friction and main coil stretched since these issues appear 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 as analyzed coil proximal contact kinked/bent and coil delivery wire kinked/bent since these issues are likely due to handling of the device during the clinical procedure.
Event or Problem Description
It was reported that during the procedure the physician was unable to advance the coil into the aneurysm.So he decide to withdrew the subject coil and while doing so it detached prematurely inside the micro catheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET 360 SOFT 7MM X 30CM
• 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: 10786159
• Report Number: 3008881809-2020-00332
• Device Sequence Number: 11806728
• Product Code: HCG
• UDI-Device Identifier: 04546540676580
• UDI-Public: 04546540676580
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/03/2020

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: 10/19/2022
• Device Model Number: M0035477300
• Device Catalogue Number: M0035477300
• Device Lot Number: 21870024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Received by Manufacturer: 10/10/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 12/04/2020
• 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: ECHELON-10 MICRO CATHETER (UNKNOWN); SYNCHRO GUIDE WIRE (STRYKER); ECHELON-10 MICRO CATHETER (UNKNOWN); SYNCHRO GUIDE WIRE (STRYKER)