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As reported, during an unspecified procedure involving a patient with cirrhosis, an advance 35 lp low profile balloon catheter's balloon leaked.A cook sheath was used, and a cook angiographic catheter was inserted into the abnormal esophageal-gastric fundal vein and embolization material, described as the appropriate amount of gelatin sponge particles, was slowly injected.The balloon catheter was then advanced over an unspecified wire guide.A pressure pump was used to inflate the balloon two times to eight atmospheres, for fifteen seconds each time; however, the balloon leaked, and blood was noted in the inflation device.The balloon was not inflated within a stent.Another device of the same type was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures or experience any adverse effects due to this occurrence.
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Summary of event: as reported, during an unspecified procedure involving a patient with cirrhosis, an advance 35 lp low profile balloon catheter's balloon leaked.A cook sheath was used, and a cook angiographic catheter was inserted into the abnormal esophageal-gastric fundal vein and embolization material, described as the appropriate amount of gelatin sponge particles, was slowly injected.The balloon catheter was then advanced over an unspecified wire guide.A pressure pump was used to inflate the balloon two times to eight atmospheres, for fifteen seconds each time; however, the balloon leaked, and blood was noted in the inflation device.The balloon was not inflated within a stent.Another device of the same type was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures or experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection and functional test of the complaint device was also conducted.The complaint device was returned to cook for investigation.A pinhole leak, near the proximal balloon bond, was noted during leak testing.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the final or sub-assembly lots.A review of complaint history found no additional complaints for this lot number.The product ifu states ¿the balloon is manufactured from an extra-thin wall, high-strength, minimally-compliant material.Particular care should be taken in handling the balloon to prevent damage.It will inflate to the indicated size parameters when utilizing proper pressure recommendations.Adhere to balloon inflation pressure parameters indicated in the compliance card insert.Refer to label for further information.Use of a pressure gauge is recommended to monitor inflation pressures.¿ a review of the device master record (dmr) 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.There is no evidence of non-conforming devices in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that a component failure, unrelated to manufacturing or design deficiencies, contributed to this event, as the anatomy was not scarred, tortuous, or calcified, and the exact conditions experienced during the event cannot be duplicated in the lab.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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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