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| Catalog Number CXI-2.6-18-150-0 |
| Device Problem
Material Separation (1562)
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| Patient Problem
No Code Available (3191)
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| Event Date 11/17/2020 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant products: kumpe catheter, stiff glidewire, advantage wire, pneumbra cat 6 device, star closure device.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 an angiogram, a cxi support catheter separated in the patient.Reportedly, the patient underwent a successful angiogram of the lower extremity on (b)(6) 2020 and was scheduled for a second angiogram on (b)(6) 2020.On the date of the second angiogram, the patient presented with right toe pain that had persisted intermittently for a few days.During the angiogram, a portion of the complaint device was discovered within the left superficial femoral artery (sfa).Reportedly, markers consistent with the distal portion of a cxi catheter were identified, including what appeared to be the tip of the catheter, located at the level of a previously placed stent.The provider noted that the separation may have occurred when they were working on another part of the body that was not in the imaging field and was therefore not seen.The physician elected to intervene to remove the retained catheter segment.Five thousand units of heparin was administered, and an unspecified 6 french ansel sheath was placed, which was then exchanged to a 7 french ansel sheath to allow for advancement of an unknown trilobed snare.The sheath was advanced up and over the bifurcation and positioned within the common femoral artery.A catheter and stiff guide wire were then advanced into the stent within the superficial femoral artery.The snare was then advanced just past the tip of the separated catheter and was slowly retracted, capturing the device, which was pulled into the sheath.Imaging confirmed that all markers were located within the sheath.Because the separated portion was unable to be removed through the hub of the sheath, the user inserted a wire guide into the distal left superficial femoral artery to maintain access and removed the 7 french sheath with the snare and catheter inside.Once the complaint device was outside the body, pressure was held to the right groin and the separated fragment was examined on the back table.Once it was confirmed that the device was removed, a new 7 french sheath and catheter were advanced up and over the bifurcation to continue the procedure.The following procedures were reportedly performed: introduction catheter into left lower extremity 3rd order catheter placement; contrast injection left lower extremity for distal runoff with additional 3rd order; retrieval portion of cxi catheter from left sfa with a trilobed snare; percutaneous transluminal angioplasty and stent placement left anterior tibial; thromboembolectomy left anterior tibial; and device closure of right common femoral arteriotomy.The overall patient outcome was reportedly good.The portion of the complaint device was removed and there was successful recanalization.
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Event Description
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Additional information was received 16dec2020.The anatomy was very calcified and fairly tortuous; however, was "not really" scarred.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Corrected information: d4= lot information was available and inadvertently omitted from the initial report.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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Manufacturer Narrative
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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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A medwatch report (mw 5098111) was received 14jan2021.Thirty centimeters of the complaint device was reportedly retained during a procedure on (b)(6) 2020.The customer confirmed that the device was found during another surgery on (b)(6) 2020.
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Event Description
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No new patient or event information since the last report was submitted.
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Manufacturer Narrative
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Event summary as reported, during an angiogram, a cxi support catheter separated in the patient.Reportedly, the patient underwent a successful angiogram of the lower extremity and was scheduled for a second angiogram.On the date of the second angiogram, the patient presented with right toe pain that had persisted intermittently for a few days.During the angiogram, a portion (thirty centimeters) of the complaint device was discovered within the left superficial femoral artery (sfa).Reportedly, markers consistent with the distal portion of a cxi catheter were identified, including what appeared to be the tip of the catheter, located at the level of a previously placed stent.The provider noted that the separation may have occurred (during the first procedure on) when they were working on another part of the body that was not in the imaging field and was therefore not seen.The anatomy was very calcified and fairly tortuous; however, was "not really" scarred.The physician elected to intervene to remove the retained catheter segment.Five thousand units of heparin was administered, and an unspecified 6 french ansel sheath was placed, which was then exchanged to a 7 french ansel sheath to allow for advancement of an unknown trilobed snare.The sheath was advanced up and over the bifurcation and positioned within the common femoral artery.A catheter and stiff guide wire were then advanced into the stent within the superficial femoral artery.The snare was then advanced just past the tip of the separated catheter and was slowly retracted, capturing the device, which was pulled into the sheath.Imaging confirmed that all markers were located within the sheath.Because the separated portion was unable to be removed through the hub of the sheath, the user inserted a wire guide into the distal left superficial femoral artery to maintain access and removed the 7 french sheath with the snare and catheter inside.Once the complaint device was outside the body, pressure was held to the right groin and the separated fragment was examined on the back table.Once it was confirmed that the device was removed, a new 7 french sheath and catheter were advanced up and over the bifurcation to continue the procedure.The following procedures were reportedly performed: 1.Introduction catheter into left lower extremity 3rd order catheter placement; 2.Contrast injection left lower extremity for distal runoff with additional 3rd order; 3.Retrieval portion of cxi catheter from left sfa with a trilobed snare; 4.Percutaneous transluminal angioplasty and stent placement left anterior tibial; 5.Thromboembolectomy left anterior tibial; and 6.Device closure of right common femoral arteriotomy.The overall patient outcome was reportedly good.The portion of the complaint device was removed and there was successful recanalization.Investigation - evaluation: a document-based investigation was performed including a review of complaint history, review of device history record, documentation, manufacturing instructions, instructions for use (ifu), and quality control data.The complaint device was not returned and thus a device failure analysis could not be performed.A search of cook¿s inventory determined that all products from the complaint lot were already out of cook¿s control and thus a representative device from the lot could not be examined.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: intended use: ¿the cxi support catheter is intended for use in small vessel or super selective anatomy for diagnostic and interventional procedures, including peripheral use.¿ precautions: ¿this product is intended for use by physicians trained and experienced in small vessel access and interventional procedures.Standard techniques for placement of percutaneous catheters should be employed.Catheter manipulation should only occur under fluoroscopy.The catheter should not be advanced into a vessel having a reference vessel diameter smaller than the catheter outer diameter.The catheter should not be advanced through an area of resistance unless the source of resistance is identified by fluoroscopy and appropriate steps are taken to reduce or remove the obstruction.¿ instructions for use: ¿2.Activate the hydrophilic coating by wetting the catheter with heparinized saline solution or sterile water.To ensure hydrophilic activation, wet the entire surface of the catheter.Note: the surface of the catheter may become dry if not used immediately after activation.Additional wetting with heparinized saline solution or sterile water will reactivate the hydrophilic coating.3.Under fluoroscopic guidance, introduce the catheter into the vascular system using standard techniques.¿ how supplied: ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ with current information, it is likely that the patient¿s anatomy and procedural issues contributed to the event.It is possible that the catheter became caught on the stent during manipulation through the tortuous, calcified anatomy.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.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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