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

Catalog Number	M0035473060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/15/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon inserting the coil into the hub of the microcatheter, the physician observed that the 5mm distal section of the coil was fractured.The coil was replaced with another similar coil.There was no patient involvement.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Analysis of the device revealed that the delivery wire kinked likely due to handling.The main coil junction was intact reflecting that the coil was attached to the delivery wire.No other anomalies were observed to the returned device.During functional evaluation resistance was experienced as the delivery wire was advanced through the introducer sheath likely due to the kinked observed.Analysis did not identify the reported break.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
It was reported that upon inserting the coil into the hub of the microcatheter, the physician observed that the 5mm distal section of the coil was fractured.The coil was replaced with another similar coil.There was no patient involvement.

• Brand Name: TARGET 360 SOFT 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: 5856939
• Report Number: 3008881809-2016-00118
• Device Sequence Number: 269983
• Product Code: HCG
• UDI-Device Identifier: 04546540676429
• UDI-Public: (01)04546540676429(17)190331(10)18942340
• 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): 07/18/2016

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 Expiration Date: 03/31/2019
• Device Catalogue Number: M0035473060
• Device Lot Number: 18942340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2016
• Supplement Report FDA Received Date: 12/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1