MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 12MM X 45CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036121240
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during coil embolization procedure with a coil (subject device), the coil broke off inside the microcatheter.There was no clinical consequences to the patient.
Additional Manufacturer Narrative
Expiration date: added.Product available to stryker: updated.Device evaluated by mfg: updated.Summary attached: updated.Manufacturing date: added.The device history record review confirms that the device met all material, assembly and performance specifications.Visual examination of the returned device revealed that the main coil was broken (from the delivery wire), kinked, and stretched.The delivery wire was found to be kinked due to handling damage.It is probable that there were procedural factors present during the clinical procedure, causing the reported and analyzed main coil broken and the other observed damages of the main coil.Therefore, an assignable cause of operational context has been assigned to this investigation.
Event or Problem Description
It was reported that during coil embolization procedure with a coil (subject device), the coil broke off inside the microcatheter.There was no clinical consequences to the patient.

• Brand Name: TARGET XL 360 SOFT 12MM X 45CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7148263
• Report Number: 3008881809-2017-00540
• Device Sequence Number: 11072353
• Product Code: HCG
• UDI-Device Identifier: 04546540711533
• UDI-Public: (01)04546540711533(17)190430(10)19024203
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K123377
• 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): 02/26/2018

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: 04/30/2019
• Device Model Number: M0036121240
• Device Catalogue Number: M0036121240
• Device Lot Number: 19024203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 02/26/2018
• 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)