H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint that the guidewire protruded through the catheter was confirmed but the cause is unknown.A single photograph of a 10cm powerglide catheter was returned for evaluation.The catheter had been completely deployed off of the deployment device.Reddish residual material was seen within the catheter shaft, indicating clinical use of the product.The catheter contained a slight bend near the distal end and the guidewire was seen protruding through the catheter in this location.The visible section of the guidewire was looped on the outside of the catheter.The observable features on the submitted photographs did not contain enough information to identify a specific root cause of the reported event.Possible contributing factors could include catheter or guidewire insertion against resistance or if the deployment device location was manipulated during the procedure.The reported complaint has been documented and will continue to be monitored in complaint trending.
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