MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035422040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is the 1st of 2 reports.Subject device is not available.
Event or Problem Description
It was reported that during coil embolization of an aneurysm located on the acom (anterior communicating artery) with sub arachnoidid bleeding, when placing the 4th coil (subject device), it came out of the microcatheter stiff and stretched.Attempt was made to place the coil but it broke off when trying to remove again.Eventually, the 4th coil was retrieved with the microcatheter, removing at the same time the 3rd implanted coil that was locked to the subject coil.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The device was returned protruding from an sl-10 microcatheter with another target coil.Visual and microscopic examination of the returned device found that the main coil was kinked/bent and stretched, the main coil suture was noted to be damaged (physical break at distal ball).The device is likely to have been damaged during use resulting in the reported events.An assignable cause of procedural factors will be assigned to the reported stretch and the analyzed issues.During analysis it was confirmed that the main coil was not broken/fractured but is likely to have been perceived to be broken due to the extensive stretching.The reported coil break cannot be confirmed based on the observed device analysis.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 during coil embolization of an aneurysm located on the acom (anterior communicating artery) with sub arachnoidid bleeding, when placing the 4th coil (subject device), it came out of the microcatheter stiff and stretched.Attempt was made to place the coil but it broke off when trying to remove again.Eventually, the 4th coil was retrieved with the microcatheter, removing at the same time the 3rd implanted coil that was locked to the subject coil.There were no clinical consequences to the patient.

• Brand Name: TARGET 360 ULTRA 2MM X 4CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7792365
• Report Number: 3008881809-2018-00356
• Device Sequence Number: 1536866
• Product Code: HCG
• UDI-Device Identifier: 04546540675842
• UDI-Public: 04546540675842
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 10/15/2018

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: 03/24/2021
• Device Catalogue Number: M0035422040
• Device Lot Number: 20405156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2018
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 10/15/2018
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER); TARGET COIL (STRYKER); EXCELSIOR SL-10 MICROCATHETER (STRYKER); TARGET COIL (STRYKER)