MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035423060
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during coil embolization procedure, the main coil prematurely detached inside the microcatheter shaft inside the patient.The coil and the microcatheter were removed from the patient as one unit.There was no impact to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The target coil was returned within an sl-10 microcatheter.Visual examination of the returned device revealed that the coil proximal contact was slightly kinked, the main coil was noted to be detached by means of electrolytic detachment, as the detachment zone had dissolved, and that the coil was jammed.During functional testing, the returned microcatheter was flushed and blood exited the distal end.Resistance was experienced during advancement of the delivery wire, therefore it was retracted back through the microcatheter and it was noted that the main coil was detached.A 0.0158¿ patency mandrel was advanced through the inner lumen of the sl-10 and the target main coil was advanced out from the distal end.Information available indicated that, the patient¿s anatomy was reported to be moderately tortuous, which may have caused or contributed to the as reported event.It is probable that the coil was damaged during the clinical procedure causing the as reported event.Therefore, an assignable cause of operational context has been assigned to the reported main coil premature detachment inside patient and to the observed coil jammed.It is probable that the proximal contact was kinked as a result of handling of the device during the clinical procedure.
Event or Problem Description
It was reported that during coil embolization procedure, the main coil prematurely detached inside the microcatheter shaft inside the patient.The coil and the microcatheter were removed from the patient as one unit.There was no impact to the patient.

• Brand Name: TARGET 360 ULTRA 3MM X 6CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6074556
• Report Number: 3008881809-2016-00242
• Device Sequence Number: 10984856
• Product Code: HCG
• UDI-Device Identifier: 04546540675880
• UDI-Public: (01)04546540675880(17)190630(10)19104821
• Combination Product (Y/N): N
• PMA/510(K) Number: K102672
• 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): 03/27/2017

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: 06/30/2019
• Device Catalogue Number: M0035423060
• Device Lot Number: 19104821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2016
• Supplement Report FDA Received Date: 03/27/2017
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)