MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2.5MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035422540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the device history record (dhr) could not be reviewed because the batch remained unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned with the concurrent microcatheter.Visual inspection was performed on the returned sample and it was observed the main coil was broken; the distal end of the coil remained inside the catheter and could not be removed.It was also observed that the main coil was stretched, and the main coil suture was damaged.Functional testing could not be performed due to the condition of the returned device.The reported events were confirmed during device analysis based on the damage noted to the device.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 returned main coil was noted to be severely damaged.The concurrent catheter was also damaged.The main coil is likely to have been damaged during the procedure resulting in the reported friction/jam.Therefore, an assignable cause of procedural factors will be assigned to this investigation.
Event or Problem Description
Based on review of the investigation of the returned product, it was found that the main coil (subject device) was broken within the microcatheter.There were no clinical consequences to the patient.

• Brand Name: TARGET 360 ULTRA 2.5MM 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: 8562178
• Report Number: 3008881809-2019-00111
• Device Sequence Number: 16603455
• Product Code: HCG
• UDI-Device Identifier: 04546540675866
• UDI-Public: 04546540675866
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/29/2019

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 Catalogue Number: M0035422540
• Device Lot Number: UNKNONW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR