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As reported, during an unspecified procedure, a hole was found in cxi support catheter.A short sheath and unspecified bentson wire were used to gain access up and over the steep iliac bifurcation.The anatomy was reportedly tortuous but the vessels were not occluded.The complaint device was then used to gain further access; however, the catheter was difficult to advance.The user aspirated and flushed the device to ensure proper placement.Reportedly, a long sheath was recommended at that time, but was not used.The user attempted to further manipulate the catheter, but was unsuccessful.Upon removal of the catheter, it was kinked at the ten-centimeter marker and a hole was noted between the forty-five and fifty-five-centimeter markers.A long sheath was then placed and the procedure was completed with another manufacturer's catheter.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Initial reporter occupation = "clinical".This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an unspecified procedure, a hole was found in cxi support catheter.A short sheath and unspecified bentson wire were used to gain access up and over the steep iliac bifurcation.The anatomy was reportedly tortuous but the vessels were not occluded.The complaint device was then used to gain further access; however, the catheter was difficult to advance.The user aspirated and flushed the device to ensure proper placement.Reportedly, a long sheath was recommended at that time, but was not used.The user attempted to further manipulate the catheter, but was unsuccessful.Upon removal of the catheter, it was kinked at the ten-centimeter marker and a hole was noted between the forty-five and fifty-five-centimeter markers.A long sheath was then placed and the procedure was completed with another manufacturer's catheter.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection of the returned device was also conducted.The complaint device was returned to cook for investigation.The catheter had kinks and flattened/compressed sections running the full length of the shaft.A hole was noted at 51.3 centimeters from the distal tip.Cook completed a review of the device history record (dhr).The dhr for the complaint lot found no relevant non-conformances.A search of complaint history on the complaint lot found no additional related complaints from the field.The catheter component lot associated with the complaint lot recorded one relevant non-conformance on one device, however, the device was scrapped.This component lot was used on 3 final lots, and a search of complaint history found no additional complaints from the field.Although this non-conformance was relevant to the reported failure mode, all non-conforming product was scrapped, there are 100% inspections to capture this non-conformance, adequate inspection activities have been established, and there are no other lot related complaints that have been received from the field.At this time, cook concluded that no non-conforming product from this lot exists in house or in the field.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: precautions: ¿the catheter should not be advanced an area of resistance unless the source of the resistance is identified under fluoroscopy and appropriate steps are taken to reduce or remove the obstruction.¿ cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.Based on the available information and results of the investigation, cook has concluded that patient anatomy was the cause of this incident.The complaint device was difficult to advance through the tortuous anatomy and over the steep iliac bifurcation.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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