MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 STANDARD 6MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035466300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2020
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.During visual inspection, the main coil severely stretched, and broken at the proximal end.The delivery wire was also noted to be kinked/bent, likely due to handling damage and the suture was damaged.Functional testing was unable to carry out as the main coil was found broken.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.Additional information provided by the customer indicated there was no damage noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition during preparation/prior to use on the patient, and the device was prepared as per the directions for use.Continuous flush was set up and maintained throughout the clinical procedure, the patient¿s anatomy was moderately tortuous and there was no patient adverse event.The damage noted to the device would be indicative of the as reported defect.The main coil was seen to be severely stretched and broken and suture damaged during analysis of the device therefore the initial reported issue main coil stretched was confirmed.It is probable the coil was damaged during the procedure as the device was being pushed into the aneurysm as indicated in the event description.The as reported and as analyzed issue main coil stretched and as analyzed issues main coil suture damage, and main coil broken/fractured during use was assigned procedural factors as these defects appear 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 or anatomical factors during use.
Event or Problem Description
Analysis of the returned device found that the coil was broken/fractured during use.There were no clinical consequences to the patient as a result of this event.

• Brand Name: TARGET 360 STANDARD 6MM X 30CM
• 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: 10660427
• Report Number: 3008881809-2020-00299
• Device Sequence Number: 11773247
• Product Code: HCG
• UDI-Device Identifier: 07613252239444
• UDI-Public: 07613252239444
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/12/2020

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: 02/15/2023
• Device Model Number: M0035466300
• Device Catalogue Number: M0035466300
• Device Lot Number: 22135319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1