MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036121040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during procedure, while the physician was re-positioning the coil (subject device) inside the aneurysm and wanted to pull the coil out again, the main coil prematurely detached at detachment zone prior to detachment process.Since the coil was still with the coil delivery wire within the micro-catheter, the physician just pushed the end of the coil into the aneurysm.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
D4: expiration date: updated.D10 returned to manufacturer on ¿updated.D10: product available to stryker: updated.H3: device evaluated by mfg: updated.H3: summary attached: updated.H4: manufacturing date: updated.The device was returned with a dispenser coil and introducer sheath.During visual inspection, the coil delivery wire was kinked/bent.The main coil was detached and not returned.The main coil was manually detached.Functional testing was not required.The reported complaint was confirmed based on analysis.The device failed to meet when received for complaint investigation based on the analyzed anomalies noted to the device.Due to the automated mes system (manufacturing execution 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.As per the additional information, the device was confirmed to be in good condition during preparation/prior to use on the patient, the device was prepared per the dfu and continuous flush was maintained throughout the procedure.The main coil was not returned since it was left inside the patient¿s aneurysm.In the case of this complaint it is most likely that the main coil prematurely detached while it was being manipulated/re-positioned during use.Therefore, the as reported event can be confirmed.The as reported and as analyzed event of main coil prematurely detached/separated during use will be assigned procedural factors as these defects appear 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 or anatomical factors during use.
Event or Problem Description
It was reported that during procedure, while the physician was re-positioning the coil (subject device) inside the aneurysm and wanted to pull the coil out again, the main coil prematurely detached at detachment zone prior to detachment process.Since the coil was still with the coil delivery wire within the micro-catheter, the physician just pushed the end of the coil into the aneurysm.There were no clinical consequences to the patient.

• Brand Name: TARGET XL 360 SOFT 10MM X 40CM
• 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: 9447378
• Report Number: 3008881809-2019-00383
• Device Sequence Number: 19393932
• Product Code: HCG
• UDI-Device Identifier: 07613327004601
• UDI-Public: 07613327004601
• 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): 01/24/2020

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: 05/05/2022
• Device Model Number: M0036121040
• Device Catalogue Number: M0036121040
• Device Lot Number: 21409212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 01/24/2020
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)