MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 4MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035474100
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during procedure while advancing the coil within the microcatheter, the coil (subject device) prematurely detached.The coil was removed with the microcatheter and the patient was re-cannulated.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual examination of the returned device revealed that the delivery wire was kinked, the main coil was extending from the distal tip of the returned sl-10 microcatheter and was extensively stretched, the coil suture was damaged, and the main coil was broken/ fractured.The broken piece of the main coil was not returned.During functional testing, the sl-10 microcatheter was flushed and the coil was advanced out from the distal end of the microcatheter, some resistance was experienced.The reported complaint was confirmed based on damage noted to the returned device.The main coil had not detached but the main coil was broken.It was probable perceived to be detached.It is probable that there were anatomical or procedural factors present during the clinical procedure which caused the main coil to break.Therefore, an assignable cause of procedural factors has been assigned to this investigation.
Event or Problem Description
It was reported that during procedure while advancing the coil within the microcatheter, the coil (subject device) prematurely detached.The coil was removed with the microcatheter and the patient was re-cannulated.There were no clinical consequences to the patient.

• Brand Name: TARGET 360 SOFT 4MM X 10CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7782115
• Report Number: 3008881809-2018-00342
• Device Sequence Number: 1757852
• Product Code: HCG
• UDI-Device Identifier: 07613252192756
• UDI-Public: 07613252192756
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 09/24/2018

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: 05/31/2021
• Device Catalogue Number: M0035474100
• Device Lot Number: LOT 20511956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1