MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 4MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035474150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, the delivery wire was noted be kinked/bent, the main coil was excessively stretched, the suture was damaged, and the main coil was broken/fractured.The distal tip was not intact due to the coil being broken.Functional testing could not be performed due to the anomalies noted to the device.In case of this complaint, the initial reported complaint indicated that friction was encountered between the target coil and a microcatheter during the procedure.The returned coil was found excessively stretched and broken.The coil got damage most likely when it was being pulled out from the microcatheter with excessive force, after it got stuck inside the catheter.Based on the investigation results and available information an assignable cause of procedural factors was assigned to the as analyzed issue main coil broken/fractured inside patient, since the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the direction for use (dfu) but due to procedural and/or anatomical factors during use, the device performance was limited.
Event or Problem Description
Analysis of the returned device found the main coil broken/fractured.There was no clinical consequences to the patient as a result of this event.

• Brand Name: TARGET 360 SOFT 4MM X 15CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8609241
• Report Number: 3008881809-2019-00124
• Device Sequence Number: 2193362
• Product Code: HCG
• UDI-Device Identifier: 04546540676481
• UDI-Public: 04546540676481
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 05/14/2019

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: 07/07/2021
• Device Catalogue Number: M0035474150
• Device Lot Number: 20716166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 05/14/2019
• 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: ECHELON10 MICORCATHETER (MEDTRONIC)