MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL HELICAL 6MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036116200
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
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 visual inspection, the device was returned together with the sl10, the main coil was found to be stuck inside the catheter, the main coil was found to be stretched, suture was found to be broken, and the main coil was found to be detached.The detachment seems to be mechanical.A functional test for coil in catheter friction ¿ fail.The coil stuck inside the catheter.The reported coil in catheter friction was confirmed during the analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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 by the customer that no damage noted to the packaging prior to opening the packaging and device was prepared as per the dfu.Also, continuous flush was maintained throughout the procedure.During analysis, the main coil was noted to be in jammed in sl-10 microcatheter.Also, the main coil was noted to be stretched and suture was damaged.Therefore, the reported event was confirmed.In the case of this complaint, it is probable that the main coil sustained damage during advancement/retraction inside the microcatheter which caused it to jam.It then likely detached prematurely when the delivery wire was pulled back.An assignable cause of procedural factors will be assigned to the as reported (ar) and (aa) ¿coil in catheter friction' , and to (aa) 'main coil stretched', 'main coil suture damage', 'coil jammed', and 'main coil prematurely detached/separated during use' since these issues are associated with a product that met stryker 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.
Event or Problem Description
The subject coil was returned for analysis and it was discovered that the subject coil was prematurely detached/separated during use.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: TARGET XL HELICAL 6MM X 20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 13344023
• Report Number: 3008881809-2022-00037
• Device Sequence Number: 19779951
• Product Code: HCG
• UDI-Device Identifier: 07613327004588
• UDI-Public: 07613327004588
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 01/25/2022

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: 10/01/2022
• Device Model Number: M0036116200
• Device Catalogue Number: M0036116200
• Device Lot Number: 21784001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR SL-10 (STRYKER); TARGET XL 360 SOFT 12MM X 45CM (STRYKER); TARGET XL 360 SOFT 18MM X 50CM (STRYKER)
• Patient Sex: Female
• Patient Race: Asian