MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 18MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036121850
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During the analysis, the coil delivery wire was found to be kinked/bent, the main coil was also seen to be kinked/bent and stretched.Also, the main coil was found to be detached from the delivery wire.Functional inspection was unable to perform the test as the main coil was found to be detached.The reported event could not be confirmed; however, the analysis results are consistent with the reported event.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.An assignable cause of procedural factors will be assigned to as reported ¿coil in catheter friction'.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 and/or anatomical factors during use.Therefore, an assignable cause of procedural factors will be assigned to as analyzed¿ main coil kinked/bent', ' main coil stretched' and ' main coil prematurely detached/separated during use'.Handling damage will be assigned to as analyzed ¿coil delivery wire kinked/bent¿ 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.
Event or Problem Description
It was reported that during procedure the subject coil encountered resistance while advancing the subject coil within the microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.Analysis of the returned device found the main coil prematurely detached/separated during use.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: TARGET XL 360 SOFT 18MM X 50CM
• 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: 12444401
• Report Number: 3008881809-2021-00370
• Device Sequence Number: 3308391
• Product Code: HCG
• UDI-Device Identifier: 04546540711564
• UDI-Public: 04546540711564
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2021

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: 01/11/2024
• Device Model Number: M0036121850
• Device Catalogue Number: M0036121850
• Device Lot Number: 22670927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 09/09/2021
• 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 (STRYKER MANUFACTURER)