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Model Number 105 |
Device Problem
Off-Label Use (1494)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/14/2022 |
Event Type
Injury
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Event Description
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Balloon burst.As per the information provided by the u.S.Distributor, (b)(6), who in turn received an email from the user facility that stated." dr.(b)(6) had to snare out one of your wedge catheters last week.The balloon rupture and broke apart.".
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Manufacturer Narrative
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The catheter and guidewire were returned in a biohazard bag.The catheter is bloody.There is a lateral tear at the center of the balloon.The distal portion of the balloon is detached.A section of the inner tubing is also detached.This section has been stretched over the guidewire.It could not be removed.The catheter was being used for aortic valvuloplasty, which is an off-label use for this catheter.The pressure the catheter was taken to before failure is unknown heavily calcified aortic valves increase the likelihood of circumferential balloon bursts.The fact that the procedure was completed with a 22 x 4 bard atlas gold (rbp 14 atm) seems to indicate that a higher pressure balloon was required to safely dilate the valve.The detachment was likely caused by attempting to pull the distal end of the balloon back through the introducer.The condition of the inner tubing is consistent with excessive force being applied to the catheter.There is a precaution in the ifu that states: "if resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.This may be accomplished by firmly grasping the balloon catheter and sheath as a unit and withdrawing both together, using a gentle twisting motion combined with traction." a review of the device history record was performed and no issues were found.All devices within the lot met all requirements for release and distribution.There have been no other complaints associated with this lot number.A review of the balloon component lot number shows there are no other complaints associated with the balloon used on this lot of catheters.A comparative catheter was tested.This catheter was the same catalog number, using the same balloon material, but a different lot number.The balloon was immersed in a body temperature water bath and inflated until it failed.The comparative catheter did not burst until 3.0 atm, which is more than the labeled rated burst pressure of 2.0 atm, and labeled nominal pressure of 1.5 atm.
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Manufacturer Narrative
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The catheter and guidewire were returned in a biohazard bag.The catheter is bloody.There is a lateral tear at the center of the balloon.The distal portion of the balloon is detached.A section of the inner tubing is also detached.This section has been stretched over the guidewire.It could not be removed.The catheter was being used for aortic valvuloplasty, which is an off-label use for this catheter.The pressure the catheter was taken to before failure is unknown heavily calcified aortic valves increase the likelihood of circumferential balloon bursts.The fact that the procedure was completed with a 22 x 4 bard atlas gold (rbp 14 atm) seems to indicate that a higher pressure balloon was required to safely dilate the valve.The detachment was likely caused by attempting to pull the distal end of the balloon back through the introducer.The condition of the inner tubing is consistent with excessive force being applied to the catheter.There is a precaution in the ifu that states: "if resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.This may be accomplished by firmly grasping the balloon catheter and sheath as a unit and withdrawing both together, using a gentle twisting motion combined with traction." a review of the device history record was performed and no issues were found.All devices within the lot met all requirements for release and distribution.There have been no other complaints associated with this lot number.A review of the balloon component lot number shows there are no other complaints associated with the balloon used on this lot of catheters.A comparative catheter was tested.This catheter was the same catalog number, using the same balloon material, but a different lot number.The balloon was immersed in a body temperature water bath and inflated until it failed.The comparative catheter did not burst until 3.0 atm, which is more than the labeled rated burst pressure of 2.0 atm, and labeled nominal pressure of 1.5 atm.
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Event Description
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Balloon burst.As per the information provided by the u.S.Distributor, (b)(4), who in turn received an email from the user facility that stated." dr.(b)(6) had to snare out one of your wedge catheters last week.The balloon rupture and broke apart.".
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Search Alerts/Recalls
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