MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421530
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not received for evaluation.
Event or Problem Description
It was reported that during a coil embolization procedure, the coil (subject device) prematurely detached inside the microcatheter.Both the microcatheter and the coil were removed and replaced and the procedure was completed successfully.There were no clinical consequences to the patient.
Event or Problem Description
It was reported that during a coil embolization procedure, the coil (subject device) prematurely detached inside the microcatheter.Both the microcatheter and the coil were removed and replaced and the procedure was completed successfully.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
Update: h4 manufacturing date ¿ added h3 device evaluated by mfg ¿updated h3 summary attached - updated d4 expiration date - added d10 product available to stryker ¿ updated d10 returned to manufacturer on ¿updated the returned product was confirmed to be the product reported in the complaint.The lot number was confirmed with the packaging returned with the device.During visual inspection, it was noted the main coil was stretched and found manually detached.The coil delivery wire was not returned for analysis.Functional inspection was unable to be carried out as the main coil was detached, however the reported events confirmed during analysis are consistent with the event.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The edhr (electronic device history record) for each lot is created and maintained in mes (manufacturing execution system).Automated controls within the mes system ensure that all product is manufactured in accordance to the dmr (device master record).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 event is anticipated and contained in the rmf.The device was returned for analysis and the reported defect was not confirmed however, the analysis results are consistent with the event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that intermittent flush was maintained.As per the dfu, ¿in order to achieve optimal performance of the target detachable coil system and to reduce the risk of thromboembolic complications, it is critical that a continuous infusion of appropriate flush solution be maintained between a) the femoral sheath and guiding catheter, b) the 2-tip microcatheter and guiding catheters, and c) the 2-tip microcatheter and stryker neurovascular guidewire and delivery wire.Continuous flush also reduces the potential for thrombus formation on, and crystallization of infusate around, the detachment zone of the target detachable coil.¿ it is probable that insufficient flush caused the reported defect.Based on the investigation results and available information an assignable cause of user error will be assigned to as reported events.

• Brand Name: TARGET 360 NANO 1.5MM X 3CM
• 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: 9897537
• Report Number: 3008881809-2020-00079
• Device Sequence Number: 2789638
• Product Code: HCG
• UDI-Device Identifier: 04546540697943
• UDI-Public: 04546540697943
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• 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): 06/04/2020

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: 10/31/2020
• Device Model Number: M0035421530
• Device Catalogue Number: M0035421530
• Device Lot Number: 20089760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 06/04/2020
• 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: LEONISMOVA MICROCATHETER (SUMITOMO)