It was reported that some time post a port placement, the catheter was allegedly broken.It was further reported that distal catheter segment migrated to the heart.Reportedly, the distal catheter segment was removed using a snare.The current status of the patient is unknown.
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H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport mri implantable port attached to a groshong catheter in two segments were returned for evaluation.Functional, gross visual, tactile, and microscopic visual evaluations were performed.The investigation is confirmed for the reported fracture and material separation issues and the identified wear and deformation issues, as complete circumferential breaks were noted on the distal end of the attached catheter and on the proximal end of the distal catheter segment.A partial circumferential break was noted approximately 0.9cm from the proximal end of the distal catheter segment.The surfaces of the complete circumferential break on the distal end of the catheter and on the proximal end of the distal catheter segment were noted to be granular in one region and glossy in the other region.The surface of the partial circumferential break on the distal catheter segment were noted to be glossy on both regions.However, the investigation is inconclusive for the reported migration issue, as the exact circumstances at the time of the reported event cannot be verified, and the reported event could not be reproduced in the lab.The identified break is typical of flexural fatigue, which is due to the repetitive, cyclic kinking of the catheter.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.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.H3 other text : see h10.
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It was reported that some time post a port placement, the catheter was allegedly broken.It was further reported that distal catheter segment migrated to the heart.Reportedly, the distal catheter segment was removed using a snare.The current status of the patient is unknown.
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