MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 14MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036101450
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not received for evaluation.
Event or Problem Description
It was reported that during the procedure the coil (subject device) prematurely detached inside the catheter.The coil was removed and the procedure completed successfully.There was no clinical consequences to the patient.
Event or Problem Description
It was reported that during the procedure the coil (subject device) prematurely detached inside the catheter.The coil was removed and the procedure completed successfully.There was no clinical consequences to the patient.
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.The device was returned and the lot number was confirmed with the packaging.During visual inspection, the proximal contact wire was intact and the coil delivery wire was severely kinked/bent.The main coil appeared to be manually detached and was removed from the catheter.Functional inspection was not required as per procedure and the reported defect was confirmed during analysis.Due to the automated mes 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.The reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The reported main coil prematurely detachment can be confirmed based on the analysis and will be assigned procedural factors 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.The analysed coil delivery wire kinked bent will be assigned handling damage as this complaint appears to be associated with handling of the product or portion of the product during the procedure a probable cause of handling damage was assigned.

• Brand Name: TARGET XL 360 STANDARD 14MM X 50CM
• 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: 10083821
• Report Number: 3008881809-2020-00154
• Device Sequence Number: 10932308
• Product Code: HCG
• UDI-Device Identifier: 04546540711298
• UDI-Public: 04546540711298
• 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): 07/15/2020

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: 12/09/2021
• Device Model Number: M0036101450
• Device Catalogue Number: M0036101450
• Device Lot Number: 21070778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 05/22/2020
• Supplement Report FDA Received Date: 07/15/2020
• 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: SL-10 CATHETER (STRYKER)