MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035424150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
It was reported that during procedure, the subject coil was inserted into the catheter; however, the coil got stuck near the microcatheter hub.The physician removed the coil and when tried to advance the coil for the second time through the microcatheter, resistance was encountered.The coil was removed and broken coil was observed.Another coil was used to complete the procedure.No patient consequences reported due to this event.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, visual, dimensional and functional testing could not be performed.Based on the additional information provided, the patient¿s anatomy was described as extremely tortuous which is likely to have contributed to the reported events.It is also possible that the main coil encountered difficulty in the form of friction when advanced through the introducer sheath and hub of the microcatheter and later broke due to some procedural factors encountered during use.While there are many potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and because the product was not returned for analysis, an assignable cause of undeterminable was assigned to the as reported issues 'nv ¿ main coil difficulty inserting ', 'nv ¿ coil introducer sheath friction', 'nv ¿ coil in catheter friction' and 'nv ¿ coil broken/fractured '.
Event or Problem Description
It was reported that during procedure, the subject coil was inserted into the catheter; however, the coil got stuck near the microcatheter hub.The physician removed the coil and when tried to advance the coil for the second time through the microcatheter, resistance was encountered.The coil was removed and broken coil was observed.Another coil was used to complete the procedure.No patient consequences reported due to this event.

• Brand Name: TARGET 360 ULTRA 4MM X 15CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7641160
• Report Number: 3008881809-2018-00284
• Device Sequence Number: 16619264
• Product Code: HCG
• UDI-Device Identifier: 04546540675941
• UDI-Public: 04546540675941
• Combination Product (Y/N): N
• 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): 08/06/2018

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: 12/31/2020
• Device Catalogue Number: M0035424150
• Device Lot Number: 20178173
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 08/06/2018
• 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); SL-10 MICROCATHETER (STRYKER)