MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2.5MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035442540
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2021
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, physician used subject coil and microcatheter.Physician noted that the subject coil could not be advanced distally within microcatheter due to the acute angle of the ica (internal carotid artery) to a1.Physician stated that the coil was detached early within the microcatheter distal part.The microcatheter and subject coil were then removed together and were replaced with similar devices.The procedure was completed successfully and no clinical consequences were noted to the patient.
Event or Problem Description
It was reported that during the procedure, physician used subject coil and microcatheter.Physician noted that the subject coil could not be advanced distally within microcatheter due to the acute angle of the ica (internal carotid artery) to a1.Physician stated that the coil was detached early within the microcatheter distal part.The microcatheter and subject coil were then removed together and were replaced with similar devices.The procedure was completed successfully and no clinical consequences were noted to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added h3 device evaluated by mfg ¿updated h3 summary attached - updated d4 expiration date - added d9 product available to stryker ¿ updated d9 returned to manufacturer on ¿updated the device was returned and the lot number was confirmed with the packaging returned with the device.The main coil was not returned.During visual inspection, the delivery wire was noted to be kinked bent and was detached/separated.Functional test unable to be preformed due to no coil been 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 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.As per the available information, there were no anomalies noted to the device prior to use, the device was prepared as per the dfu, continuous flush was maintained for the duration of the procedure, the coil couldn't be advanced in the micro catheter distal part.(at the acute angle) and the micro catheter was located at the acute angle ica to a1.It is probable that the damage to the device occurred during the attempt to advance beyond the acute angle ica to a1.An assignable cause of procedural factors will be assigned to the reported main coil prematurely detached/separated during use, coil in catheter friction and to the analyzed coil delivery wire kinked bent and main coil prematurely detached/separated during use, as this complaint 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.

• Brand Name: TARGET 360 NANO 2.5MM 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: 11499246
• Report Number: 3008881809-2021-00122
• Device Sequence Number: 19826356
• Product Code: HCG
• UDI-Device Identifier: 07613252600305
• UDI-Public: 07613252600305
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 06/28/2021

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: 08/09/2022
• Device Model Number: M0035442540
• Device Catalogue Number: M0035442540
• Device Lot Number: 21569619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 06/28/2021
• 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); PHENOM 017 MICROCATHETER (MEDTRONIC)