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), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a kinked guidewire is confirmed but the exact cause remains unknown.Two photo samples of a guidewire were provided for evaluation.The first photo is of the product information label.The label indicates lot: refx4608.The second photo shows a guidewire within its hoop and is being held by the clinician.A portion of the guidewire is extending past the distal end of the hoop.A ¿z¿ shaped kink is present in the wire.The characteristics of the guidewire could not be closely examined from the image provided.Based on the information provided, possible contributing factors include damage to the guidewire during storage or handling.The cause and location at which the damage occurred remains unknown.Since a kink in the guidewire was observed, the complaint is confirmed but the exact cause remains unknown.
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