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Product complaint # (b)(4).Information regarding patient date of birth, height, and medical history was not provided.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.
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As reported by a healthcare professional, during a balloon-assisted thrombectomy of a moderately tortuous left m1 segment middle cerebral artery (mca) occlusion, the prowler select plus 150/5cm (606s255x/30068834) microcatheter crossed the occlusion, but the 5x33 embotrap ii (et009533/unk lot) revascularization device could not be inserted through the hub of the microcatheter.The rotating hemostasis valve (rhv) was loosened and tightened again to ensure it was not too tight but the embotrap ii would not advance.The prowler select plus microcatheter was removed, resulting in a loss of cerebral target position, and the catheter was replaced with a competitor device.The same embotrap ii was advanced through the competitor microcatheter without incident.The embotrap ii removed the occlusion and flow was restored after two passes.No patient complications occurred as a result of the event.The surgery was delayed a few minutes due to the event, and the procedural delay was not considered clinically significant.No visible product damage/defect was noted.The concomitant embotrap ii did not appear damaged in any way.The complaint product was stored and handled according to the instructions for use (ifu).The user did not apply excessive force when handling the devices.An adequate continuous flush was maintained through the catheter.The patient was initially transferred from the emergency room to the lab with elevated nih stroke scale score and tissue plasminogen activator (tpa) was administered.Access was made with a diagnostic catheter.A 8f x 85 balloon guide catheter was advanced to the left internal carotid artery (ica).The event occurred before the first pass was made with the embotrap ii device.The product and concomitant revascularization device will be returned for evaluation.No further information was provided.
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Product complaint #
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> (b)(4).Updated sections: [complaint conclusion] as reported by a healthcare professional, during a balloon-assisted thrombectomy of a moderately tortuous left m1 segment middle cerebral artery (mca) occlusion, the prowler select plus 150/5cm (606s255x/30068834) microcatheter crossed the occlusion, but the 5x33 embotrap ii (et009533/unk lot) revascularization device could not be inserted through the hub of the microcatheter.The rotating hemostasis valve (rhv) was loosened and tightened again to ensure it was not too tight but the embotrap ii would not advance.The prowler select plus microcatheter was removed, resulting in a loss of cerebral target position, and the catheter was replaced with a competitor device.The same embotrap ii was advanced through the competitor microcatheter without incident.The embotrap ii removed the occlusion and flow was restored after two passes.No patient complications occurred as a result of the event.The surgery was delayed a few minutes due to the event, and the procedural delay was not considered clinically significant.No visible product damage/defect was noted.The concomitant embotrap ii did not appear damaged in any way.The complaint product was stored and handled according to the instructions for use (ifu).The user did not apply excessive force when handling the devices.An adequate continuous flush was maintained through the catheter.The patient was initially transferred from the emergency room to the lab with elevated nih stroke scale score and tissue plasminogen activator (tpa) was administered.Access was made with a diagnostic catheter.An 8f x 85 balloon guide catheter was advanced to the left internal carotid artery (ica).The event occurred before the first pass was made with the embotrap ii device.No further information was provided.A non-sterile prowler select plus 150/5cm was received inside of a pouch.The device was visually inspected, and the hub was found with residues of dried blood.No damage was observed.The catheter body was inspected and was found compressed at 5.6 cm from the distal end.Residues of dried blood were also noted on the catheter body.The distal tip was inspected, and no damage was observed.No other damages were noted on the received device.The device was inspected under microscope and the compressed condition and the residues of dried blood observed during visual analysis were confirmed.The inner diameter (id) and outer diameter (od) from were measured and were found within specification.The catheter was flushed with a lab sample syringe, and a.018¿ lab sample guidewire was introduced into the microcatheter hub.The guidewire was advanced through the microcatheter and resistance/friction was felt when the guidewire passed through the compressed section of the microcatheter.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.The customer report of catheter obstructed was not confirmed during functional testing.The sample guidewire could be advanced through the microcatheter.However, resistance/friction was encountered as the guidewire was advanced through the compressed section of the microcatheter.The event description states that the customer could not introduce the embotrap ii device through the hub of the microcatheter.The presence of blood in the microcatheter hub suggests that an insufficient flush was maintained.The ifu states that continuous infusion of an appropriate flush solution is required for optimal performance, and also indicates that the flush should be verified in the event of resistance.Insufficient flush allows blood to back-flow into the microcatheter, which can cause resistance.Without the return of the concomitant embotrap ii device, the cause of the reported event cannot be determined.The exact circumstances surrounding the observed damage to the catheter cannot be determined based on the condition of the returned device.However, it is possible that the kink occurred during storage, shipping, or processing after the reported event.Catheter obstructed is a known potential product failure associated with the use of the device.The ifu contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.Neither the product analysis nor the device history record review suggests that the failure could be related to the manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the information provided and the evidence presented by the sample article; however, it is possible that procedural and handling factors, including device manipulation, may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.
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