MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 9MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035479300
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a neurovascular procedure, resistance was felt while advancing the subject coil through the catheter.When retrieved, it was found that the subject coil had separated from the delivery wire inside the micro-catheter.The subject coil was replaced, and 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.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.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the patient's anatomy was not tortuous, the treatment site was located in the acomm (anterior communicating), an microcatheter was used with the subject coil, there was friction when pushing the coil and it was difficult to retract, and there was no attempt made to detach the coil using an power supply system.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned for analysis, an assignable cause of undeterminable was assigned to as reported 'coil in catheter friction' and 'main coil prematurely detached/separated during use'.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The product was returned, the coil delivery wire was found to be kinked/bent in multiple areas.The main coil was found to be broken off the coil delivery wire.The broken/fractured main coil was found inside the microcatheter.The main coil was found to be stretched.The suture was found to be damaged.The main coil was found to be kinked/bent.The coil introducer sheath was found to be intact.A functional inspection was unable to be performed due to the condition of the returned device.The reported coil in catheter friction could not be replicated; however, the analysis results are consistent with the reported event.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.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared for use as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the patient's anatomy was not tortuous, the treatment site was located in the acomm (anterior communicating artery), a microcatheter was used with the subject coil, there was friction when pushing the coil and it was difficult to retract, and there was no attempt made to detach the coil using a power supply system.The as reported (ar) 'main coil prematurely detached/separated during use' was not confirmed based on the visual inspection as the main coil was found to be broken/fractured and the implant was not separated at the detachment zone.Since the returned microcatheter was found to be kinked on its shaft, it is probable that this caused resistance during manipulation of the subject coil inside the microcatheter which resulted in the subsequent damage observed on the coil (kinked, stretched, broken, suture damaged).Therefore, caused by other will be assigned to the as reported 'coil in catheter friction' as well the as analyzed 'main coil broken/fractured during use', 'main coil stretched', main coil kinked/bent' and 'main coil suture damage' since the investigation indicates another product caused the issue event.An assignable cause of handling damage will be assigned to the as analyzed 'coil delivery wire kinked/bent' since this issue is associated with handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.
Event or Problem Description
It was reported that during a neurovascular procedure, resistance was felt while advancing the subject coil through the catheter.When retrieved, it was found that the subject coil had separated from the delivery wire inside the micro-catheter.The subject coil was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 SOFT 9MM X 30CM
• 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: 16900011
• Report Number: 3008881809-2023-00236
• Device Sequence Number: 6837424
• Product Code: HCG
• UDI-Device Identifier: 04546540676627
• UDI-Public: 04546540676627
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 07/17/2023

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: 02/19/2025
• Device Model Number: M0035479300
• Device Catalogue Number: M0035479300
• Device Lot Number: 23490950
• 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: 04/20/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2022
• 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
• Patient Sex: Unknown