MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 3MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035473080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during an endovascular procedure in a patient the subject coil pusher wire broke during introducing the coil into the microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No other information is available.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual/microscopic inspection, the coil delivery wire was noted to be kinked.The coil delivery wire was noted to be broken.There were no anomalies noted to the coil.Functional inspection 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.The reported event was confirmed based on the device analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The device was prepared for use as per the dfu.There was no damage noted to the packaging prior to opening the packaging.Additional information provide was the pusher wire of coil broke during introducing the coil into the microcatheter.An assignable cause of not confirmed will be assigned to the as reported coil delivery wire broken/fractured during use as the event was not confirmed during the analysis according to the event description, the event happened outside the patents body.An assignable cause of 'handling damage' will be assigned to the as analyzed 'coil delivery wire broken/fractured during preparation' and 'coil delivery wire kinked/bent' as the defect appears to be associated with handling of the product or portion of the product during preparation.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 an endovascular procedure in a patient the subject coil pusher wire broke during introducing the coil into the microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No other information is available.

• Brand Name: TARGET 360 SOFT 3MM 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: 17385440
• Report Number: 3008881809-2023-00374
• Device Sequence Number: 6302240
• Product Code: HCG
• UDI-Device Identifier: 04546540676436
• UDI-Public: 04546540676436
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/12/2023

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: 09/16/2023
• Device Catalogue Number: M0035473080
• Device Lot Number: 22443482
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2020
• 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: UNKNOWN MICROCATHETER
• Patient Sex: Unknown