COOK INC BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
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Model Number G09548 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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E1: customer name and address = postal code: (b)(6).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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As reported, during a procedure involving repair of an endoleak, the tip of a beacon tip torcon nb advantage angiographic catheter separated.The patient had previously undergone an endovascular aneurysm repair (evar) procedure.Reportedly, upon gaining access, the physician was unable to thread an unspecified wire through the left limb of the pre-existing evar stent graft.Prior to placing an unspecified 5-french sheath, the user threaded the complaint device over the wire guide, placing the wire and catheter through the left limb of the stent graft.A push-pull technique was used to remove the catheter, at which point the tip of the device separated in the patient's soft tissue.The physician removed the separated tip from the patient with mosquito forceps, without losing wire access.Additional information has been requested.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.H6 (annex g) h3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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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In additional information received on 17oct2023, it was reported that the access site was scarred due to a prior evar and common femoral endarterectomy with patch angioplasty.The beacon tip catheter was advanced into the abdominal aorta over a wire guide through a common femoral endarterectomy with patch angioplasty, rather than the pre-existing evar stent graft as originally reported.The beacon tip was not inserted or advanced through any type of sheath.A super stiff wire from another manufacturer was used.The patient did have tortuous anatomy, which was why the catheter was inserted over a wire for purchase prior to insertion of the sheath.Mild resistance was felt during insertion through soft tissue.Similar resistance was experienced during removal of the catheter.The device was not used with a power injector.Upon return of the complaint device, the catheter shaft was separated at the tip and below the hub.
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Manufacturer Narrative
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Investigation ¿ evaluation.As reported, during a procedure involving repair of an endoleak, the tip of a beacon tip torcon nb advantage angiographic catheter separated.The patient had previously undergone an endovascular aneurysm repair (evar) and common femoral endarterectomy with patch angioplasty.The beacon tip catheter was advanced into the abdominal aorta over a wire guide through the previously scarred, tortuous vessel.The beacon tip was not inserted or advanced through any type of sheath.A super stiff wire from another manufacturer was used.The patient did have tortuous anatomy, which was why the catheter was inserted over a wire for purchase prior to insertion of an unspecified 5-french sheath.Mild resistance was felt during insertion through soft tissue.Similar resistance was experienced during removal of the catheter.The device was not used with a power injector.A push-pull technique was used to remove the catheter, at which point the tip of the device separated in the patient's soft tissue.The physician removed the separated tip from the patient with mosquito forceps, without losing wire access.No adverse effects to the patient have been reported.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.The complainant returned one beacon tip torcon nb advantage angiographic catheter to cook for investigation.Physical examination of the complaint device revealed that the tip was separated from the catheter, the tip measured 3 cm and the shaft measured 44 cm (elongation seems to be present).Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the device history record (dhr).The dhr for the reported lot records no nonconformances.A subassembly lot recorded one relevant nonconformance, in which the device was scrapped, and the lot is inspected 100%.A database search for complaints reported on the complaint lot reveals no additional complaints at this time.Therefore, cook determined that no nonconforming product exists in house or in the field.Cook reviewed the product labeling.The product ifu, t_hnb_rev2 ¿beacon tip catheters¿ provides the following information to the user related to the reported failure mode: precautions manipulation of catheter requires fluoroscopic control.If resistance is encountered during manipulation, stop and determine the cause before proceeding any further.Instructions for use 1.Inspect the packaging and device to verify no damage.Do not use the product if the catheter or packaging is damaged.5.Under fluoroscopic guidance, advance the catheter over an appropriately sized wire guide or through an appropriately sized sheath introducer to the intended location.Note: if resistance is encountered during manipulation, stop and determine the cause before proceeding any further.How supplied upon removal from package, inspect the product to ensure no damage has occurred.The information provided upon review of the returned device, complaint file, dmr, dhr, and ifu does not indicate that the device was manufactured out of specification.Based on the information provided, inspection of the returned device, and the results of the investigation, cook concluded that a combination of patient anatomy and procedural issues caused this incident.The user stated that resistance was encountered both during advancement and withdrawal from a scarred and tortuous vessel.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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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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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Manufacturer Narrative
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**udi related data quality updates only** this report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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