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	05/21/2020
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 procedure, the proximal portion of the subject coil¿s pusher wire kinked and then broke while being pushed into the microcatheter.The physician tried to detach the subject coil to see if it could still be detached despite being broken at the proximal end.The subject coil was unable to detach and was completely removed from patient anatomy.The physician replaced the subject coil with a new device and continued the procedure without any clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date added.D4 expiration date added.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.Additional information was provided by the customer stated the device was confirmed to be in good condition during preparation/prior to use on the patient and the device prepared for use as per the directions for use.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned to the reported event.
Event or Problem Description
It was reported that during procedure, the proximal portion of the subject coil¿s pusher wire kinked and then broke while being pushed into the microcatheter.The physician tried to detach the subject coil to see if it could still be detached despite being broken at the proximal end.The subject coil was unable to detach and was completely removed from patient anatomy.The physician replaced the subject coil with a new device and continued the procedure without any 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.The device was returned.The lot number was confirmed with the packaging returned with the device.On visual inspection, the proximal contact and the delivery wire were noted to be kinked/bent.The main coil was returned attached to the delivery wire.The proximal contact was examined under magnification and was noted to be broken/fractured.Functional test was unable to be completed as the proximal contact was broken/fractured.The reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation.Additional information was provided by the customer stated the device was confirmed to be in good condition during preparation/prior to use on the patient and the device prepared for use as per the directions for use.It is probable that the delivery wire kinked and the proximal contact fractured in the attempt to insert the proximal end of the delivery wire into the inzone to complete the coil detachment, resulting in the failure to detach the main coil.An assignable cause of procedural factors will be assigned to the reported main coil failed/unable to detach, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.It is probable that the proximal contact detached as a result of handling of the device during preparation of the device or during advancement of the device.An assignable cause of handling damage will be assigned to the reported coil delivery wire broken/ fractured during use, coil delivery wire kinked/bent and the analyzed defects coil delivery wire kinked/bent & coil proximal contact broken/fractured.
Event or Problem Description
It was reported that during procedure, the proximal portion of the subject coil¿s pusher wire kinked and then broke while being pushed into the microcatheter.The physician tried to detach the subject coil to see if it could still be detached despite being broken at the proximal end.The subject coil was unable to detach and was completely removed from patient anatomy.The physician replaced the subject coil with a new device and continued the procedure without any clinical consequences to the patient.

• 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 ; EI NA
• MDR Report Key: 10160104
• Report Number: 3008881809-2020-00176
• Device Sequence Number: 2706443
• Product Code: HCG
• UDI-Device Identifier: 07613252239345
• UDI-Public: 07613252239345
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 12/09/2020

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: 12/14/2022
• Device Model Number: M0035422060
• Device Catalogue Number: M0035422060
• Device Lot Number: 22019510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 07/28/2020; 11/12/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 08/11/2020; 12/09/2020
• 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: ECHELON-10 MICRO CATHETER (MEDTRONICS).; SYNCHRO GUIDE WIRE (STRYKER).
• Patient Age: 38 YR