COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number G50317 |
Device Problem
Material Separation (1562)
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Patient Problem
No Code Available (3191)
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Event Date 09/27/2019 |
Event Type
Injury
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Manufacturer Narrative
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Pma/510(k) number: k170193.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
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Event Description
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As reported, during angioplasty of the left radial artery, the balloon separated from an advance 14 lp low profile balloon catheter shaft.Access was obtained in the right groin and a cook hydro st wire guide was used to cross the lesion, which was reportedly 85% occluded, in the left radial artery.The vessels were reported to be highly calcified with 45 degree-angulation noted.Two cook ansel (6 french, 90 centimeter and 4 french, 110 centimeter) sheaths were used during the procedure.The complaint device was advanced through the lesion and inflated one time to 12 atmospheres for 90 seconds, using a 50/50 ratio of an unknown contrast to saline solution.An attempt to further advance the balloon was not successful; therefore, the physician pulled the balloon out by itself.The device came out with "not a lot of pressure".An unknown manufacturer's 1.5 millimeter balloon was advanced, however would not cross the lesion.Another unknown balloon was also unable to cross the lesion.The wire guide was then exchanged for an unknown "stiffer" wire.The physician noticed at that point that there were still balloon markers on the screen.The complaint device was examined and the balloon was found to be completely disconnected from the catheter.The physician started to perform a cutdown procedure to remove the device; however a snare was found prior to cutting into the artery.The separated portion of the device was then removed with the snare.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Manufacturer Narrative
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Additional information: 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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Event Description
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Additional information was received on 17oct2019 and 21oct2019.Negative pressure was maintained; however, a counterclockwise rotation was not performed upon removal of the device.A portion of the device did not remain in the patient's body.
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Manufacturer Narrative
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Event summary: as reported, during angioplasty of the left radial artery, the balloon separated from an advance 14 lp low profile balloon catheter shaft.Access was obtained in the right groin and a cook hydro st wire guide was used to cross the lesion, which was reportedly 85% occluded, in the left radial artery.The vessels were reported to be highly calcified with 45 degree-angulation noted.The complaint device was advanced through the lesion and inflated one time to 12 atmospheres for 90 seconds, using a 50/50 ratio of an unknown contrast to saline solution.An attempt to further advance the balloon was not successful; therefore, the physician pulled the balloon out by itself with "not a lot of pressure".Negative pressure was maintained; however, a counterclockwise rotation was not performed upon removal of the device.Following two unsuccessful attempts at advancing another manufacturer¿s balloon through the lesion, the physician noticed balloon markers on imaging.The complaint device was examined and the balloon was found to be completely disconnected from the catheter.The separated portion of the device was then completely removed with the snare.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), manufacturing instructions, and quality control procedures of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.A document-based investigation evaluation was thus conducted.A review of the device history record did shows nonconforming events which could have contributed to this failure mode.All affected product was scrapped, however, and was not replaced.A review of complaint history showed no additional complaints received related to this lot.Reviews of the manufacturing instructions and quality control procedures were also conducted, and no gaps were discovered.The available information provides objective evidence to support that the device was manufactured to specification.The product is packaged with instructions for use which warns, 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, which resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures.The ifu further advises, ¿if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.Based on the information available, investigation has concluded that a definitive cause could not be established for this event.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.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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Event Description
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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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Search Alerts/Recalls
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