MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 20MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036122050
Medical Device Problem Codes	Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
During the embolization procedure inside the patient, it was reported that the coil was stretched in the microcatheter.The physician had to snare it and ended up getting it out with a retriever.No further information is available.
Additional Manufacturer Narrative
(¿no known device problem¿ is added to replace ¿difficult to remove¿).
Event or Problem Description
During the embolization procedure inside the patient, it was reported that the coil was stretched in the microcatheter.The physician had to snare it and ended up getting it out with a retriever.No further information is available.
Additional Manufacturer Narrative
Age at time of event and age units (patient): updated.Gender: updated.Executive summary: updated with additional information received on 6-sep-2017.Expiration date: added.Manufacturing date: added.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.Information available indicated that the device was confirmed to be in good condition after unpacking and the device was prepared as per the dfu.Based on the information currently available the exact cause for the reported event cannot be determined.
Event or Problem Description
During the embolization procedure inside the patient, it was reported that the coil was stretched in the microcatheter.The physician had to snare it and ended up getting it out with a retriever.The physician reported that she felt resistance when advancing the coil through the microcatheter initially.No clinical consequences reported to the patient.

• Brand Name: TARGET XL 360 SOFT 20MM X 50CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6829260
• Report Number: 3008881809-2017-00272
• Device Sequence Number: 64974
• Product Code: HCG
• UDI-Device Identifier: 07613327004618
• UDI-Public: (01)07613327004618(17)190831(10)19260502
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 11/21/2017

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: 08/31/2019
• Device Model Number: M0036122050
• Device Catalogue Number: M0036122050
• Device Lot Number: 19260502
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2017
• Supplement Date Received by Manufacturer: 08/04/2017; 10/27/2017
• Initial Report FDA Received Date: 08/29/2017
• Supplement Report FDA Received Date: 08/30/2017; 11/21/2017
• 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: Other; Required Intervention
• Patient Age: 75 YR