MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 4MM X 12CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036124120
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2020
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 coil (subject device) was stuck within the microcatheter.Upon removal the subject coil was prematurely detached and was removed from the patient.The procedure was completed successfully and no clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
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.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the subject coil proximal contact wire was intact.The subject coil delivery wire was broken and the main coil was not returned.Functional testing could not be carried out as the main coil was detached and was not returned.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 stated that there were no anomalies noted to the device prior to use.The as reported, main coil prematurely detached/separated during use was confirmed.In the case of this complaint it is most likely that the main coil detached when attempting coil advancement/retrieval against friction.The reported event coil in catheter friction was not confirmed however, the analysis results are consistent with the event.This complaint appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.Therefore, an assignable cause of procedural factors will be assigned to the reported and analyzed events.
Event or Problem Description
It was reported that during the procedure the coil (subject device) was stuck within the microcatheter.Upon removal the subject coil was prematurely detached and was removed from the patient.The procedure was completed successfully and no clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XL 360 SOFT 4MM X 12CM
• 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: 9796367
• Report Number: 3008881809-2020-00058
• Device Sequence Number: 10923346
• Product Code: HCG
• UDI-Device Identifier: 07613327128338
• UDI-Public: 07613327128338
• 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): 04/30/2020

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 Expiration Date: 08/20/2022
• Device Model Number: M0036124120
• Device Catalogue Number: M0036124120
• Device Lot Number: 21674711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1