MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that the microcatheter was used with the subject coil embolization.When delivering the subject coil in the microcatheter, the resistance encountered in the microcatheter and it was stuck in the microcatheter.During withdrawal ,the subject coil was fractured in microcatheter.The physician replaced it with a different new coil and completed the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that the microcatheter was used with the subject coil embolization.When delivering the subject coil in the microcatheter, the resistance encountered in the microcatheter and it was stuck in the microcatheter.During withdrawal ,the subject coil was fractured in microcatheter.The physician replaced it with a different new coil and completed the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.H4 manufacturing date ¿ added.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual inspection of the coil (subject device) revealed that the coil delivery wire was found to be kinked/bent.The main coil had been separated from the delivery wire and was found in the returned excelsior xt-17 microcatheter.Functional testing could not be performed due to the condition of the returned device as the main coil was found to be detached.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.Information from the complaint indicated that an excelsior xt-17 microcatheter was used in the procedure.The coil was prepared for use per the dfu and was confirmed to be in good condition prior to use.Continuous flush was set up and the patient's anatomy was moderately tortuous.During analysis, the coil delivery wire was found to be kinked/bent.The main coil had been separated from the delivery wire and was found in the returned excelsior xt-17 microcatheter.In the case of this complaint, it is likely that procedural factors contributed to difficulty advancing the coil in the xt-17 microcatheter during the case causing the coil to mechanically separate from the delivery wire when manipulated against the reported resistance inside the microcatheter.Based on the investigation, an assignable cause of procedural factors will be assigned to the as reported and analyzed since these issues appear 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 and/or anatomical factors during use.An assignable cause of handling damage will be assigned to the analyzed 'coil delivery wire kinked/bent' since this defect most likely resulted from handling of the device during the procedure, upon removal of the product from its packaging, or preparation of the product prior to use.

• Brand Name: TARGET 360 NANO 1.5MM 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: 11666984
• Report Number: 3008881809-2021-00163
• Device Sequence Number: 3127943
• Product Code: HCG
• UDI-Device Identifier: 04546540697998
• UDI-Public: 04546540697998
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 07/14/2021

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: 11/15/2023
• Device Model Number: M0035421540
• Device Catalogue Number: M0035421540
• Device Lot Number: 22575697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Received by Manufacturer: 03/28/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 07/14/2021
• 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: XT17 MICROCATHETER (STRYKER)
• Patient Age: 57 YR
• Patient Weight: 70