MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036125150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure, coil embolization was performed using a microcatheter and coils.The microcatheter was guided into the abdominal blood vessel.When the subject coil was used for the 6th coil out of the 11 total coils used, the subject coil was stuck and was not able to be pushed inside the microcatheter so it was collected.After collection, it was noted that subject coil was broken and was discarded.Physician completed the procedure successfully and no clinical consequences were noted to the patient.No further information was provided.
Additional Manufacturer Narrative
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.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 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.Information from the complaint indicated that a breakthrough microcatheter (bsc) was used in the procedure and the subject coil was the 6th coil used out of 11 coils in total.No further information was available.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 this complaint.
Event or Problem Description
It was reported that during the procedure, coil embolization was performed using a microcatheter and coils.The microcatheter was guided into the abdominal blood vessel.When the subject coil was used for the 6th coil out of the 11 total coils used, the subject coil was stuck and was not able to be pushed inside the microcatheter so it was collected.After collection, it was noted that subject coil was broken and was discarded.Physician completed the procedure successfully and no clinical consequences were noted to the patient.No further information was provided.

• Brand Name: TARGET XL 360 SOFT 5MM X 15CM
• 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: 11545591
• Report Number: 3008881809-2021-00133
• Device Sequence Number: 17126576
• Product Code: HCG
• UDI-Device Identifier: 07613327128291
• UDI-Public: 07613327128291
• 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): 04/30/2021

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: 07/08/2023
• Device Model Number: M0036125150
• Device Catalogue Number: M0036125150
• Device Lot Number: 22318087
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 04/30/2021
• 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: BREAKTHROUGH MICROCATHETER (BOSTON SCIENTIFIC)