MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 7MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035477150
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
During an attempt to coil an artery, the physician encountered resistance at the tip of the competitor microcatheter.The physician pulled back the microcatheter while pushing forward the coil; however, resistance was still met.It was reported that when delivery wire was retracted, the coil remained in the microcatheter.Since the competitor microcatheter was being used to infuse medication, the microcatheter along with the coil were removed and placed in a radiation disposal bag.There was no reported clinical consequence to the patient due to this event.
Additional Manufacturer Narrative
Additional information clarified that the coil did not exit the competitor microcatheter and became jammed inside the microcatheter.The coil remained attached to the delivery wire and it was safely removed along with microcatheter.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
During an attempt to coil an artery the physician encountered resistance at the tip of the competitor microcatheter.The physician pulled back the microcatheter while pushing forward the coil; however, resistance was still met.It was reported that when delivery wire was retracted, the coil remained in the microcatheter.The coil did not exit the microcatheter and it was jammed.The coil remained attached to the delivery wire.Since the competitor microcatheter was being used to infuse medication, the microcatheter along with the coil were safely removed and placed in a radiation disposal bag.There was no reported clinical consequence to the patient due to this event.

• Brand Name: TARGET 360 SOFT 7MM 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: 5822236
• Report Number: 3008881809-2016-00094
• Device Sequence Number: 13612954
• Product Code: HCG
• UDI-Device Identifier: 04546540676566
• UDI-Public: (01)04546540676566(17)180930(10)18622815
• 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): 07/05/2016

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 Catalogue Number: M0035477150
• Device Lot Number: 18622815
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2016
• Supplement Report FDA Received Date: 08/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR