MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 6MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036126200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During visual inspection, the main coil was found severely tangled, stretched and kinked/bent.The suture of the coil and the main coil junction were broken.Functional testing could not be performed since the main coil was not returned.In case of this complaint, the main coil was tangled, kinked/bent and stretched (suture was damage) and this may have caused friction in the introducer sheath which would have caused friction in the catheter; therefore, an assignable cause of procedural factor was assigned to the as analyzed issue main coil broken/fractured inside patient, since the analyzed issue appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the direction for use (dfu), but performance was limited due to procedural or anatomical factors during use.
Event or Problem Description
Analysis of the returned device found that the coil was broken/fractured.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: TARGET XL 360 SOFT 6MM X 20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8651751
• Report Number: 3008881809-2019-00148
• Device Sequence Number: 2129879
• Product Code: HCG
• UDI-Device Identifier: 07613327004625
• UDI-Public: 07613327004625
• 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): 05/29/2019

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 Expiration Date: 05/12/2021
• Device Catalogue Number: M0036126200
• Device Lot Number: 20522184
• 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: 05/09/2019
• Initial Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 75