MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 7MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036107200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the coiling of posterior cerebral artery while the subject coil was being repositioned, the catheter tip migrated out of the aneurysm making it unable to position the subject coil.While attempting to remove the subject coil, it stretched and was unable to remove.A snare device was used to capture the subject coil and catheter and the devices were removed successfully.The procedure was aborted and scheduled for a later date.There were no clinical consequences to the patient due to this event.
Additional Manufacturer Narrative
F10/h6 - health code updated to "unexpected medical intervention".Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product 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 by the customer indicated that there were no allegations reported against the microcatheter, it is unknown what snare device was used, condition of patient is stable, there were no injuries during the surgery and resistance was encountered when retracting the coil in an attempt to remove it.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to the as reported events patient medical or surgical intervention required, main coil stretched, main coil friction and device interaction with another device.H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during the coiling of posterior cerebral artery while the subject coil was being repositioned, the catheter tip migrated out of the aneurysm making it unable to position the subject coil.While attempting to remove the subject coil, it stretched and was unable to remove.A snare device was used to capture the subject coil and catheter and the devices were removed successfully.The procedure was aborted and scheduled for a later date.There were no clinical consequences to the patient due to this event.

• Brand Name: TARGET XL 360 STANDARD 7MM 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: 15691299
• Report Number: 3008881809-2022-00535
• Device Sequence Number: 15130198
• Product Code: HCG
• UDI-Device Identifier: 07613327004762
• UDI-Public: 07613327004762
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/03/2024
• Device Model Number: M0036107200
• Device Catalogue Number: M0036107200
• Device Lot Number: 23057330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 SL10 MICROCATHETER (STRYKER); GUIDE CATHETER (UNKNOWN); SNARE (UNKNOWN)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown