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Model Number G44153 |
Device Problems
Break (1069); Unraveled Material (1664)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 03/11/2022 |
Event Type
Injury
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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.
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Event Description
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As reported, during a blow-the-knee revascularization procedure, a flexor ansel guiding sheath separated.Heparin was given for anticoagulation.Access was obtained in the right groin, which was reportedly very scarred and hard from a previous femoral-popliteal procedure.Resistance was not encountered upon insertion of the sheath, as the physician reportedly anticipated difficult access and used an unknown 6 french dilator to dilate the access site prior to advancing the sheath.A contralateral approach was used to successfully complete the procedure, treating the left superficial femoral artery and lesions below the knee with angioplasty and atherectomy.Advancement of the sheath over the bifurcation was described as very minimally challenging.Upon removal of the sheath over an amplatz wire with a floppy tip, the sheath unraveled and separated twelve-to-fifteen centimeters from the hub.The dilator was not reinserted into the sheath prior to removal and was not in the sheath lumen at the time of separation.Per the reporter, the physician was very cautious when removing the sheath, as he knew it could break, so he pulled from the proximal shaft, without use of force.Unraveled coils were reported at the access site, and the separated portion of the sheath remained in the body, up and over the bifurcation, over the wire.The physician held pressure at the access site and used another manufacturer¿s 5 french short sheath to maintain hemostasis.Vascular surgery and interventional radiology were consulted, and the decision was made to attempt retrieval endovascularly.An unknown 8 french short sheath was used to obtain access in the left groin, and a gooseneck snare was used to snare the amplatz wire, creating a ¿wire floss¿ from the right to left groin.The user then attempted to snare the separated sheath with the same snare; however, this was unsuccessful, as the tip of the separated sheath was getting bent at the tip of the 8 french sheath.Another manufacturer¿s 5 french, 45-centimeter sheath was then placed in the right groin, using a dilator, over the same amplatz wire.The new sheath was used to push the separated sheath toward the left groin.At the same time, another physician pulled the separated sheath from the left groin, using a snare, through the 8 french short sheath.The separated sheath was removed completely from the left groin and both access sites were closed successfully.The entire procedure took less than one hour to complete.Per the reporter, the patient did not experience any adverse effects due to this occurrence.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during a blow-the-knee revascularization procedure, a flexor ansel guiding sheath separated.Heparin was given for anticoagulation.Access was obtained in the right groin, which was reportedly very scarred and hard from a previous femoral-popliteal procedure.Resistance was not encountered upon insertion of the sheath, as the physician reportedly anticipated difficult access and used an unknown 6 french dilator to dilate the access site prior to advancing the sheath.A contralateral approach was used to successfully complete the procedure, treating the left superficial femoral artery and lesions below the knee with angioplasty and atherectomy.Advancement of the sheath over the bifurcation was described as very minimally challenging.Upon removal of the sheath over an amplatz wire with a floppy tip, the sheath unraveled and separated twelve-to-fifteen centimeters from the hub.The dilator was not reinserted into the sheath prior to removal and was not in the sheath lumen at the time of separation.Per the reporter, the physician was very cautious when removing the sheath, as he knew it could break, so he pulled from the proximal shaft, without use of force.Unraveled coils were reported at the access site, and the separated portion of the sheath remained in the body, up and over the bifurcation, over the wire.The physician held pressure at the access site and used another manufacturer¿s 5 french short sheath to maintain hemostasis.Vascular surgery and interventional radiology were consulted, and the decision was made to attempt retrieval endovascularly.An unknown 8 french short sheath was used to obtain access in the left groin, and a gooseneck snare was used to snare the amplatz wire, creating a ¿wire floss¿ from the right to left groin.The user then attempted to snare the separated sheath with the same snare; however, this was unsuccessful, as the tip of the separated sheath was getting bent at the tip of the 8 french sheath.Another manufacturer¿s 5 french, 45-centimeter sheath was then placed in the right groin, using a dilator, over the same amplatz wire.The new sheath was used to push the separated sheath toward the left groin.At the same time, another physician pulled the separated sheath from the left groin, using a snare, through the 8 french short sheath.The separated sheath was removed completely from the left groin and both access sites were closed successfully.The entire procedure took less than one hour to complete.Per the 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 were conducted during the investigation.The complaint device was not returned to cook for investigation.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The product ifu warns, ¿reinsertion of dilator prior to removal of flexor sheath increases the strength of the sheath and lessens the risk of device separation.If resistance is anticipated or encountered during withdrawal of flexor sheath, consider carefully reinserting the dilator prior to continuing removal.¿ the information provided upon review of the dmr, dhr, and ifu provide evidence that the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that a cause could not be established for this event.There is currently a capa investigation open to further investigate this product failure mode.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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 has been received since the last report was submitted.
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Search Alerts/Recalls
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