MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035442040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that during the procedure, a coil (subject device) encountered resistance inside the middle part of the microcatheter.The physician made an attempt to collect the subject coil but when the it was brought to the proximal part of the microcatheter, it was found that the subject main coil was not attached at the tip of its delivery wire.The physician searched the surgical field, all the other conjunction devices and inside the patient's skull but could not find it.The physician removed the microcatheter and flushed the lumen outside the patient's anatomy but the subject coil did not come out of the microcatheter.The physician delivered a guidewire inside the microcatheter but it got caught at the proximal end of the microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during the procedure, a coil (subject device) encountered resistance inside the middle part of the microcatheter.The physician made an attempt to collect the subject coil but when the it was brought to the proximal part of the microcatheter, it was found that the subject main coil was not attached at the tip of its delivery wire.The physician searched the surgical field, all the other conjunction devices and inside the patient's skull but could not find it.The physician removed the microcatheter and flushed the lumen outside the patient's anatomy but the subject coil did not come out of the microcatheter.The physician delivered a guidewire inside the microcatheter but it got caught at the proximal end of the microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil delivery wire was seen to be kinked and bent.The main coil was seen to be detached from the pusher wire and the main coil was stuck within the catheter shaft.The shaft was cut and the coil was removed.The coil was damaged during this process (cut and stretched) and therefore it cannot be determined it this damage occurred during the procedure.Functional inspection was not carried out due to condition of returned device.The reported complaint was confirmed based on 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.The as reported as well as the as analyzed main coil detached during use and coil jammed will be assigned procedural factors as it appears to be 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 factors during use.The coil delivery wire was also seen to be kinked bent and this will be assigned handling damage as it appears this complaint appears to be associated with handling of the product or portion of the product during the procedure.

• Brand Name: TARGET 360 NANO 2MM X 4CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11531861
• Report Number: 3008881809-2021-00132
• Device Sequence Number: 11896469
• Product Code: HCG
• UDI-Device Identifier: 07613252600299
• UDI-Public: 07613252600299
• 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): 07/15/2021

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: 11/03/2023
• Device Model Number: M0035442040
• Device Catalogue Number: M0035442040
• Device Lot Number: 22558606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR SL-10 MICROCATHETER (STRYKER); TARGET COIL (STRYKER); UNKNOWN GUIDEWIRE