MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 14MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036101450
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	06/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned.
Event or Problem Description
It was reported that during the procedure, resistance was encountered when advancing the subject coil and the coil became stretched inside the microcatheter shaft.The subject coil was pulled back with a gooseneck snare.Another coil was used to complete the procedure.There were no clinical consequences reported due to this event.
Additional Manufacturer Narrative
The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, visual, dimensional and functional testing could not be performed.In case of this complaint, the additional information provided by the customer indicated that no damage was noted to the coil prior to use and the target coil was prepared as per direction for use (dfu).While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, an assignable cause of undeterminable was assigned to the as reported issues.
Event or Problem Description
It was reported that during the procedure, resistance was encountered when advancing the subject coil and the coil became stretched inside the microcatheter shaft.The subject coil was pulled back with a gooseneck snare.Another coil was used to complete the procedure.There were no clinical consequences reported due to this event.

• Brand Name: TARGET XL 360 STANDARD 14MM 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: 8801912
• Report Number: 3008881809-2019-00211
• Device Sequence Number: 13533160
• Product Code: HCG
• UDI-Device Identifier: 04546540711298
• UDI-Public: 04546540711298
• 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): 08/13/2019

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: 02/29/2020
• Device Catalogue Number: M0036101450
• Device Lot Number: 19577691
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 08/13/2019
• 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: A GOOSENECK SNARE (UNKNOWN MANUFACTURER); A GOOSENECK SNARE (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR