MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 3MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035443040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The reported event is covered in the device directions for use (dfu).As well, 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 subject coil was returned within a dispenser coil in the introducer sheath.The lot number was confirmed with the packaging returned with the device.During visual inspection, the proximal contact wire was intact.The coil delivery wire was broken and the delivery wire was kinked/bent.The distal tip was found to be intact.The main coil was kinked/bent.During functional testing, the subject coil friction in catheter test had failed.The coil was flushed and advanced in a demonstration microcatheter, there was resistance felt.The main coil was seen to be kinked bent and this was causing friction in the catheter.This confirms the as reported.The as reported as well as the as analyzed main coil kinked bent and coil in catheter friction will be assigned procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.The cause of coil delivery wire to be kinked bent and broken would have been caused by handling when friction was felt.The as analyzed coil delivery wire kinked bent and coil delivery wire broken/fractured during use will be assigned handling damage as it appears to be associated with handling of the product or portion of the product during the procedure.
Event or Problem Description
Analysis of the returned subject coil revealed that the coil delivery wire had broken/fractured during use.Therefore, based on this information the event is deemed reportable with an awareness date of (b)(6) 2021.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 NANO 3MM X 4CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11400066
• Report Number: 3008881809-2021-00109
• Device Sequence Number: 4759784
• Product Code: HCG
• UDI-Device Identifier: 07613252600336
• UDI-Public: 07613252600336
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 03/02/2021

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: 09/09/2023
• Device Model Number: M0035443040
• Device Catalogue Number: M0035443040
• Device Lot Number: 22426737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1