MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 12MM X 45CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036121240
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	06/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, physician was placing the subject coil and while repositioning, it got tangled with the coils already placed in the aneurysm and got stretched.Physician tried to remove the whole setup but the microcatheter was also stretched and ultimately physician used a snare device to remove the subject coil.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During the visual inspection, returned main coil was noted to be partially protruding the distal end of a catheter.The catheter was noted to be severely stretched.The main coil was noted to be stuck in the catheter and could not be removed.The main coil protruding the catheter was noted to be kinked/bent.The main coil protruding the catheter was noted to be stretched with strands of suture visible.Functional testing was not required.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 the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the coil was advanced slowly and gently without applying excessive force, and no torque was given where advancing the delivery wire.Based on the information provided, it is likely that the subject coil got tangled with the other coils in the aneurysm during placement and during attempts to pull the coil back with the microcatheter, both the coil and the catheter got stretched.The subsequent kinking and suture damage likely occurred once the coil was jammed in the stretched catheter and was pushed/pulled against resistance.An assignable cause of procedural factors will be assigned to the as reported /as analyzed main coil stretched, device interaction with another device'; to as reported patient medical or surgical intervention required; and to as analyzed main coil suture damage, catheter, coil jammed, main coil kinked/bent in this complaint 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
It was reported that during the procedure, physician was placing the subject coil and while repositioning, it got tangled with the coils already placed in the aneurysm and got stretched.Physician tried to remove the whole setup but the microcatheter was also stretched and ultimately physician used a snare device to remove the subject coil.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XL 360 SOFT 12MM X 45CM
• 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: 12199829
• Report Number: 3008881809-2021-00306
• Device Sequence Number: 11132996
• Product Code: HCG
• UDI-Device Identifier: 04546540711533
• UDI-Public: 04546540711533
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/10/2021

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: 01/26/2023
• Device Model Number: M0036121240
• Device Catalogue Number: M0036121240
• Device Lot Number: 22083022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2020
• 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: GOOSENECK SNARE (UNKNOWN); MICROCATHETER (TOKAI MEDICAL CARNELIAN); GOOSENECK SNARE (UNKNOWN); MICROCATHETER (TOKAI MEDICAL CARNELIAN)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 80 KG