COOK INC ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number N/A |
Device Problems
Balloon rupture (1049); Material Rupture (1546)
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Patient Problems
Foreign body, removal of (2365); No Code Available (3191)
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Event Date 12/05/2014 |
Event Type
Injury
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Event Description
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Upon ballooning, the balloon ruptured on the plaque and broke off into multiple pieces.Pieces had to be snared out.Imaging did not show any remaining pieces.
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Manufacturer Narrative
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(b)(4).The event is currently under investigation.
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Manufacturer Narrative
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(b)(4).Investigation a review of complaint history, instructions for use (ifu), quality control, trends, and a visual inspection of the returned device were conducted during the investigation.One balloon catheter was returned for investigation.A visual examination of the device noted the balloon ruptured circumferentially.The tip material broke off the catheter and the balloon was broken into 3 pieces.The ifu, states under the warnings heading, ¿do not exceed rated burst pressure.Rupture of balloon may occur.Adhere to balloon inflation pressure parameters in the compliance card insert.Over-inflation may cause rupture of the balloon, with resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures.Do not use a power injector for balloon inflation.Rupture may occur.¿ the balloon is designed to burst longitudinally which minimizes the risk of balloon and/or catheter separation upon devices withdrawal.Detection activities have been conducted; the reason for this failure cannot be determined.We will notify the appropriate internal personnel and continue to monitor for similar complaints.
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Event Description
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Upon ballooning, the balloon ruptured on the plaque and broke off into multiple pieces.Pieces had to be snared out.Imaging did not show any remaining pieces.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Upon ballooning, the balloon ruptured on the plaque and broke off into multiple pieces.Pieces had to be snared out.Imaging did not show any remaining pieces.
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Search Alerts/Recalls
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