MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035422060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2020
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 the subject coil was delivered in microcatheter, but resistance was encountered even when retracting.Upon removal of subject device from patient anatomy, found that the coil fractured from delivery wire.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that during the procedure the subject coil was delivered in microcatheter, but resistance was encountered even when retracting.Upon removal of subject device from patient anatomy, found that the coil fractured from delivery wire.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Device was returned for analysis and product lot number was confirmed from the packaging label.During visual inspection, it was noted that subject device was returned without coil and was observed to have a broken delivery wire.Functional tests could not be performed as the subject device was returned without coil portion.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.As per the additional information, there was no damage noted to the packaging and the device was confirmed to be in good condition during preparation/prior to use, the device was prepared per the directions for use, there was no difficulty encountered during removal of the device from the packaging hoop and continuous flush was maintained throughout the procedure.The coil broke from the push wire when the coil was pushed inside the microcatheter tube.The coil was not advanced or retracted with force.The patient¿s anatomy was moderately tortuous.The damage noted to the device would be indicative of the as reported defects coil in catheter friction, coil delivery wire broken/fractured during use and coil difficult to remove/withdraw from catheter.The coil was not returned for analysis but the coil delivery wire was returned broken which would indicate significant friction was encountered in the microcatheter which subsequently led to the coil breaking during device withdrawal.The reported defects coil in catheter friction, coil delivery wire broken/fractured during use and coil difficult to remove/withdraw from catheter as well as the as analyzed coil delivery wire broken/fractured during use will be assigned procedural factors as these defects 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 or anatomical factors during use.

• Brand Name: TARGET 360 ULTRA 2MM X 6CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 10176295
• Report Number: 3008881809-2020-00180
• Device Sequence Number: 16759663
• Product Code: HCG
• UDI-Device Identifier: 07613252239345
• UDI-Public: 07613252239345
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 08/05/2020

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: 07/23/2021
• Device Model Number: M0035422060
• Device Catalogue Number: M0035422060
• Device Lot Number: 20746646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Initial Date Received by Manufacturer: 05/24/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 08/05/2020
• 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: SL-10 MICROCATHETER (STRYKER); SYNCHRO2 GUIDEWIRE (STRYKER); SL-10 MICROCATHETER (STRYKER); SYNCHRO2 GUIDEWIRE (STRYKER)
• Patient Age: 63 YR