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Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.The company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
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Product complaint # (b)(4).Updated sections on this report: b5, e1, e2, e3, g4, g7, h2, h3, h6, and h10.Based on the additional information received, the device code ¿fracture¿ has been added to this report.B5:additional information received further clarified that the damage was noted during removal from package.No excessive force was applied while handling the device.The device was stored and handled according to the ifu.There was no damage noted to the packaging (i.E.Creased, torn).The physician noticed that the joint was bent and when he looked closely, he also noticed that it was broken.The basket part was in the insertion tool in the hoop.The physician took out the embotrap from the hoop then the basket part was taken out from the insertion tool.It is unclear if other medical staff manipulated (or touched) the complaint product.It was the first time for the hospital to use this device.Section e1.Initial reporter phone: (b)(6).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during a thrombus removal of an acute ischemic stroke (ais), the pouch of 5x33 embotrap ii revascularization device (et009533, 20a020av) was opened but the join part of the delivery wire and the cell was bent.The complaint device was replaced with another device and the procedure continued.Additional information received clarified that the complaint device was not used in the patient because the issue was noticed when it was taken out from the hoop when opening.It was taken out from the pouch as per the instructions for use (ifu) and the issue was noticed when it was taken out from the hoop.Additional information received further clarified that the damage was noted during removal from package.No excessive force was applied while handling the device.The device was stored and handled according to the ifu.There was no damage noted to the packaging (i.E.Creased, torn).The physician noticed that the joint was bent and when he looked closely, he also noticed that it was broken.The basket part was in the insertion tool in the hoop.The physician took out the embotrap from the hoop then the basket part was taken out from the insertion tool.It is unclear if other medical staff manipulated (or touched) the complaint product.It was the first time for the hospital to use this device.The embotrap ii 5x33mm device was returned due to the device being deemed to be deformed and fractured at the proximal struts upon opening the device.It was confirmed by the customer that the device was inside the insertion tool when the customer took the device out from the packaging hoop.The deformation and fracture were noted when the device was removed from the insertion tool and visually examined by the user before device use.The initial examination of the returned embotrap device confirmed the strut deformation at the proximal outer cage and the strut fracture at the proximal inner channel.This deformation is consistent with damage caused by forwarding the device against resistance (such as forwarding the device into a lumen 0.021¿ or forwarding the device when deployed).Segments 1, 2, 3 and 4 had no evidence of strut damage.The visual inspection also indicates that the return embotrap device was correctly assembled and manufactured, with all adhesive bonds and joints complete and undamaged.The ptfe insertion tool was dimensionally inspected and found to be undamaged and within specification for the inner diameter and outer diameter.A review of the embotrap ii rmf identified the following possible root causes: 1.During inspection or packaging of the assembly by manufacturing operator: 1-1.The deformation/fracture of the device could have occurred during in-process inspection of the embotrap sub assembly.During this inspection the device is advanced out of the insertion tool for visual inspection for damage and foreign material.It is possible that the mishandling of the device caused the deformation/structure.However further inspection of the device, required by the manufacture procedures, would detect such damage.1-2.The damage also could occur when the trained operators inspect the strut damage or fracture, and position assembly into the insertion tool approximately 30mm±15mm from end of insertion tool as per the procedure.It is possible that mishandling at this step could cause the device to be damaged.There is no visual inspection of the device after this step, however resistance to positioning the device within the insertion tool would be noted by the operator if the strut was damaged as per the returned product, it is therefore considered unlikely that the damage was caused at this step.1-3.As the deformation is indicative of resistance to a forward motion, it is also possible that the device was inadvertently advanced from the insertion tool whilst packaging the device in the packaging hoop.There is no visual inspection of the device after this step, and it is unlikely that the operator would detect this handling error, however damage to the more distal regions of the device would be anticipated by this error.(note: an additional inspection post this stage is not possible without requiring re-packaging steps and would therefore introduce additional risk of product damage through handling.It is determined that the risk of damage by introduction of a visual inspection therefore outweighs the benefit.During handling of the device by the customer: 2-1.It is possible that the device was inadvertently moved forwarded from the insertion tool whilst still in the hoop during handling the device by the customer.For example, it is possible that person opening the device packaging (sterile barrier) and preparing the device for the user mishandled the device causing the device to deform by pushing the device forward whilst still in the hoop without realizing it.The user may have also mishandled the device by manipulating it incorrectly during preparation due to unfamiliar with the device.It was confirmed that it was the first time to use an embotrap device for the hospital.However, on discussions with the user, it was confirmed that the user was confident that this did not occur.A review of the dhr confirmed that this lot was assembled correctly and no record of difficulty in loading the device in the insertion tool or packaging hoop recorded.The reported customer complaint ¿proximal coil kinked/bent¿ and ¿proximal coil fractured¿ was been confirmed.The return embotrap device exhibits that the device was deformed and fractured at the proximal outer cage and inner channel upon opening of the device.The dhr review recorded that all the devices were demonstrated to be assembled correctly.Although the exact root cause could not be determined, it is determined that the residual risk associated with this failure mode and possible root causes remains low and acceptable as reflected in the embotrap ii rmf.Analysis of the potential root cause identified two probable root causes: manufacturing error, operator mishandling and user error, user mishandling.Based on information provided to us by the user, it is concluded that the most probably root cause is manufacturing error, i.E.Operator error during packaging of the sub-assembly into the packaging hoop.An internal action has been opened to address this issue.
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