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Model Number N/A |
Device Problem
Unraveled Material (1664)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Customer (person) postal code: (b)(6).Initial reporter occupation: advanced practice nurse (apn).Pma/510(k) #: exempt.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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It was reported an unknown patient required placement of a lock pericardiocentesis catheter set for an unknown procedure.During the procedure, a first device of an unknown lot number was "affected".A second device was used, and the physician noted the guidewire unraveled.A third device was used to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
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Event Description
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It was reported an unknown patient required placement of a lock pericardiocentesis catheter set for an unknown procedure.During the procedure, a first device of an unknown lot number was "affected".A second device was used, and the physician noted the guidewire unraveled.A third device was used to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
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Manufacturer Narrative
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(b)(6).Pma/510(k) #: exempt.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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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unchanged, or unavailable.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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Per additional information provided on 10jan2022: elderly lady with liver cirrhosis complicated with recurrent ascites required abdominal paracentesis.During the procedure, the needle was inserted and clear ascetic fluid was noted to be draining out.The guidewire was introduced smoothly without resistance.The needle was removed and the dilator was inserted smoothly.The dilator was removed and the pigtail was advanced over the guidewire smoothly.When the guidewire was attempted to be removed, resistance was experienced.The guidewire was noted to be frayed and spring coils could be seen.The physician could not remove the guidewire any further.The entire pigtail catheter along with the wire guide was removed.Once removed from the abdomen, the guidewire was able to be removed from the pigtail catheter.No kinks were observed, however the guidewire was unraveled.A second device of a different lot number was used to complete the procedure successfully.The patient did not have tortuous anatomy and the wire was manipulated through the needle provided in the set.Additional information clarified there was only one device that failed in this event.No other devices failed during this procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
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Manufacturer Narrative
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Investigation ¿ evaluation: (b)(6) hospital (singapore) contacted cook stating that when they used the catheter from a c-pcs-830-lock set from lot# 13827770, the wire guide unraveled.The wire guide was initially passed through a needle without issue.A dilator and pigtail catheter were advanced over the wire guide without issue.When the user withdrew the wire guide through the catheter, the wire guide unraveled.The wire guide and catheter were removed as a unit, and the procedure was completed with a replacement device.The patient did not have tortuous anatomy.Cook became aware of this event on (b)(6) 2021.Reviews of the complaint history, device history record (dhr), quality control, and instructions for use (ifu) were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.The customer provided photos of the complaint device that confirmed the wire guide to be in an unraveled state.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot (13827770) and the related subassembly lots revealed one non-conformance for lot# 13827770 and determined the non-conformance not relevant to the reported failure.Wire guide subassembly lot was reviewed and cook found no non-conformances.A database search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.This product is supplied with an instructions for use (ifu) pamphlet c_t_ttps_rev10.In the precautions section it states: a tfe-coated wire guide must be used with the catheter in this set.Only the wire guide included in this set should be used with this catheter.In the instructions for use section, it states: 5) slide the safe-t-j wire guide straightener (positioned on the distal end of the wire guide) over the ¿j¿ portion of the wire guide and seat the straightener in the hub of the needle.6) insert the wire guide through the needle and advance the wire guide into the pericardial sac.Note: the wire guide should advance without resistance.7) leaving the wire guide in place, remove the needle.8) if a dilator is included in set, the dilator should be advanced over the wire guide and removed prior to insertion of the catheter.9) introduce the catheter (with stiffening cannula, if applicable) over the wire guide and advance until the tip of the catheter is posterior to the muscle fascia.11) advance the catheter into the pericardium.Note: the wire guide should always extend beyond the catheter tip.12) remove the wire guide.In the how supplied section it states: upon removal from package inspect the product to ensure no damage has occurred.Based on the information provided, no product returned, and the results of the investigation, the most likely cause for this failure is component failure.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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Search Alerts/Recalls
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