MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035421020
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record confirms that the device met all material, assembly and performance specifications.Visual inspection was performed and on the returned sample and it was observed that the proximal contact wire and the coil delivery wire were kinked and bent.Functional testing revealed that device could not be advanced in the catheter.The catheter was flushed and could not be advanced.The introducer sheath was cut was in order to remove the main coil and the device was retracted.The device was started to be in good use and was prepared according to the directions for use specifications.The reported events are covered in the device directions for use.The risks of the reported events are documented in the risk documentation and there are current controls to mitigate the risk of the as reported events.The cause for the reported issues could be determined.It is probable that the devise was damaged during the clinical procedure due to some procedural /anatomical factors encountered causing the as reported evens, therefore assignable cause of procedural factors will be assigned to the reported issue.
Event or Problem Description
Analysis of the returned devise found the subject coil delivery wire broken inside the patient.It was reported there was a 30-minute delay in the procedure.The patient¿s medical condition was good and there was no adverse event.There were no clinical consequences reported to the patient.

• Brand Name: TARGET 360 NANO 1MM X 2CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 9447477
• Report Number: 3008881809-2019-00384
• Device Sequence Number: 19355331
• Product Code: HCG
• UDI-Device Identifier: 04546540697967
• UDI-Public: 04546540697967
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 12/10/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: M0035421020
• Device Lot Number: 19997579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR