MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036101040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Waiting for investigation.The device history record confirms that the device met all material, assembly and performance specifications.Visual inspection was performed on the returned sample and it was observed that the proximal contact wire was found to be intact, the coil delivery wire was kinked bent, and the main coil appears to have been detached as it was not returned with the device.Function testing was not carried out as the main coil was not retuned.The device was stated to be in good condition and was prepared according to the dfu specifications.The reported issue is covered in the device directions for use.The risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported complaint was confirmed based on analysis.From analysis, it can be seen that the main coil was detached from the pusher wire which would confirm the as reported event.It can be presumed that the main coil difficulty inserting and coil in catheter friction would have led to the premature detachment.Therefore assignable cause of procedural factors will be assigned to reported issue.
Event or Problem Description
While withdrawing the coil (subject device), the physician experienced friction and the coil deployed within the microcatheter.There were no clinical consequences to the patient.

• Brand Name: TARGET XL 360 STANDARD 10MM X 40CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8529975
• Report Number: 3008881809-2019-00104
• Device Sequence Number: 1899800
• Product Code: HCG
• UDI-Device Identifier: 04546540711274
• UDI-Public: 04546540711274
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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
• Report Date (Section B): 04/18/2019

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: 10/06/2021
• Device Catalogue Number: M0036101040
• Device Lot Number: 20928491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1