MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 3D 4MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036154080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the coil embolization procedure, the physician placed the coil (subject device) into the aneurysm.The proximal part of delivery wire of the subject coil broke and the physician was unable to detach the subject coil.The physician removed the subject coil from the patient anatomy.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Additional Manufacturer Narrative
H3 device evaluated by mfg: updated.H3 summary attached: updated.H4 manufacturing date: added.D4 expiration date: added.D10 product available to stryker: updated.D10 returned to manufacturer on: updated.Due to the automated mes system, there are controls in the manufacturing process to ensure the product met specifications upon release.During visual/microscopic inspection, the coil delivery wire was seen to be kinked/bent.The coil proximal contact was seen to be broken.The main coil was intact.The functional inspection was not carried out due to a break on the proximal contact.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 the subject coil could not be detached.It was also reported that the device was prepared as per the dfu, that there was no damage noted to the packaging prior to opening and the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush maintained throughout the procedure.During device analysis, the coil delivery wire was found to be kinked/bent and the coil proximal contact was found to be broken.The main coil was found to be intact.In the case of this complaint, it is likely that the delivery wire and proximal contact damage was caused due to handling when inserting the device into the detachment system causing the reported detachment failure.Therefore, the as reported ¿main coil failed/unable to detach, as well as the as analyzed ¿coil delivery wire kinked/bent¿ and ¿coil proximal contact wire broken/fractured¿ 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.The as reported ¿coil delivery wire broken/fractured during use¿ will be assigned not confirmed as the coil delivery wire was returned and no breaks were found present during device analysis.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that during the coil embolization procedure, the physician placed the coil (subject device) into the aneurysm.The proximal part of delivery wire of the subject coil broke and the physician was unable to detach the subject coil.The physician removed the subject coil from the patient anatomy.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 3D 4MM X 8CM
• 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: 14617796
• Report Number: 3008881809-2022-00277
• Device Sequence Number: 4949237
• Product Code: HCG
• UDI-Device Identifier: 04546540711670
• UDI-Public: 04546540711670
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 08/31/2022

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: 02/08/2024
• Device Model Number: M0036154080
• Device Catalogue Number: M0036154080
• Device Lot Number: 22638238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2021
• 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: INZONE DETACHMENT SYTEM (STRYKER)
• Patient Sex: Unknown