(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be performed since a correct lot number was not provided by the customer and a potential lot could not be determined from a review of sales history for this customer.Without the device to evaluate, the complaint could not be confirmed , and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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According to the medwatch (mfr report# 3012279212-2019-00003): "(b)(6)-year-old female auto vs.Pedestrian trauma presented in the evening.Patient was hemodynamically unstable on presentation.X-ray revealed vertical shear pelvic fracture.The user facility did not report which introducer sheath was used or whether the prytime er-reboa convenience kit was used.Therefore, it is unknown which introducer sheath was used.However, the user facility stocks the prytime er-reboa convenience kit thus it is possible that this kit, with the included arrow medical super arrow flex 7 fr introducer sheath, was used to gain femoral access.Access was gained int he right common femoral artery and the er-reboa catheter was placed with no issues.The catheter was only "briefly" deployed.Upon removal of the introducer sheath the following morning, the patient displayed diminished pulses in the right lower extremity.There were concerns about a right common femoral/external iliac artery dissection and clot after viewing the ct.A thrombectomy was performed during which the artery was found to be normal".
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