MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 12MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035471230
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available to manufacturer.
Event or Problem Description
It was reported that during an aneurysm case, when advancing the subject coil inside the microcatheter, the resistance was encountered, therefore; the subject coil was withdrawn, and it was found to be broken in the microcatheter.The subject coil and microcatheter were removed together as a unit.The operator replaced them with a new microcatheter and new coil to finish the procedure.There were no clinical consequences to the patient due to the reported event.
Event or Problem Description
It was reported that during an aneurysm case, when advancing the subject coil inside the microcatheter, the resistance was encountered, therefore; the subject coil was withdrawn, and it was found to be broken in the microcatheter.The subject coil and microcatheter were removed together as a unit.The operator replaced them with a new microcatheter and new coil to finish the procedure.There were no clinical consequences to the patient due to the reported event.
Additional Manufacturer Narrative
The edhr (electronic device history record) for the device lot is created and maintained in mes (manufacturing execution system).Automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Analysis of the returned device revealed the delivery wire was kinked due to handling of the device during use.Additionally, the main coil was found to be stretched and detached from the delivery wire.The functional test could not be performed due to the condition of the returned device.In the case of this complaint it is most likely that friction was met inside the microcatheter due to some procedural/anatomical factors encountered during the procedure.It is likely that the coil got stuck inside the catheter and it then kinked, stretched and detached prematurely from the delivery wire while it was being withdrawn from the catheter against friction.Based on the analysis results and available information, an assignable cause of procedural factors will be assigned to this investigation.

• Brand Name: TARGET 360 SOFT 12MM X 30CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8467126
• Report Number: 3008881809-2019-00085
• Device Sequence Number: 1628494
• Product Code: HCG
• UDI-Device Identifier: 07613252192671
• UDI-Public: 07613252192671
• 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): 06/03/2019

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: 09/28/2021
• Device Catalogue Number: M0035471230
• Device Lot Number: 20894910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 06/03/2019
• 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)
• Patient Age: 65 YR