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	01/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure subject coil was advancing up through the microcatheter.While in the microcatheter subject coil experienced resistance and did not reach the aneurysm.Physician proceeded to remove coil only to find that the subject coil had been prematurely detached from the delivery wire within microcatheter.No clinical consequences were reported to the patient due to this event.No further information is provided.
Additional Manufacturer Narrative
The device was returned in a non-stryker catheter.The lot number was confirmed from the packaging label.During visual inspection, the catheter was cut to clarify the main coil was not inside and there was no main coil found in the shaft.The coil delivery wire was kinked/bent and the main coil was detached from the pusher wire.Functional inspection was not performed.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.The main coil was seen to be detached.The as reported as well as the as analysed nv - main coil prematurely detached/separated during use will be assigned procedural factors.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.The coil delivery wire was seen to be kinked bent, it can be assumed this occurred when friction was felt in the procedure.The as analysed nv - coil delivery wire kinked bent will be assigned handling damage as this complaint appears to be associated with handling of the product or portion of the product during the procedure.
Event or Problem Description
It was reported that during the procedure subject coil was advancing up through the microcatheter.While in the microcatheter subject coil experienced resistance and did not reach the aneurysm.Physician proceeded to remove coil only to find that the subject coil had been prematurely detached from the delivery wire within microcatheter.No clinical consequences were reported to the patient due to this event.No further information is provided.

• 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: 11311467
• Report Number: 3008881809-2021-00074
• Device Sequence Number: 14118464
• Product Code: HCG
• UDI-Device Identifier: 07613252600299
• UDI-Public: 07613252600299
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 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: 09/21/2023
• Device Model Number: M0035442040
• Device Catalogue Number: M0035442040
• Device Lot Number: 22458371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 02/10/2021
• 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: MICROCATHETER (UNKNOWN)