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

Catalog Number	M0035443060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During placement of the finishing coil (subject device), the coil was repositioned and stretched and it was reported the coil was completely removed from the patient with a snare device.There was no clinical consequence to the patient as a result of this event.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.Analysis of the returned device found the proximal contact and main coil was kinked; no additional anomalies were noted.There was blood in the introducer sheath when it was flushed which can indicate flush was maintained during procedure, however, the coil was advanced through the introducer sheath without resistance.Although the coil was not found to be stretched as reported, the kinked sections may have been perceived as stretched; the reported event can be confirmed.Based on device analysis and the information available, it is probable the device was damaged due to some procedural/anatomical factors encountered during procedure, causing the reported medical intervention.As such, an assignable cause of operational problem due to component failure was assigned to this event.
Event or Problem Description
During placement of the finishing coil (subject device), the coil was repositioned and stretched and it was reported the coil was completely removed from the patient with a snare device.There was no clinical consequence to the patient as a result of this event.

• Brand Name: TARGET 360 NANO 3 MM X 6 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7555471
• Report Number: 3008881809-2018-00246
• Device Sequence Number: 2194277
• Product Code: HCG
• UDI-Device Identifier: 07613252600329
• UDI-Public: 07613252600329
• 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): 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: M0035443060
• Device Lot Number: 20053936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 08/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention