MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035423060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that the delivery wire broke during procedure.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual inspection was performed on the returned sample and there were no anomalies noted to the delivery wire, however, the coil proximal contact was seen to be detached/ separated at the proximal contact bond.Functional testing was not performed.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 not confirmed based on analysis, there was no break observed on the delivery wire, therefore a cause of not confirmed will be assigned to the investigation.The proximal contact is not a contiguous part that forms the delivery wire, but is a subcomponent located at the proximal end of the delivery wire that works in conjunction with the inzone detachment system, and it remains outside the patient at all times during the procedure.It is highly unlikely that the broken proximal contact may contribute to and/or cause any patient injury; therefore, this record has been deemed non-reportable.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that the delivery wire broke during procedure.There were no clinical consequences to the patient.

• Brand Name: TARGET 360 ULTRA 3MM X 6CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8849064
• Report Number: 3008881809-2019-00225
• Device Sequence Number: 14020170
• Product Code: HCG
• UDI-Device Identifier: 04546540675880
• UDI-Public: 04546540675880
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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,Followup
• Report Date (Section B): 09/21/2019

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: 09/10/2021
• Device Catalogue Number: M0035423060
• Device Lot Number: 20863576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 09/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR