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It was reported that the wire guide in a cook spectrum minocycline/rifampin impregnated five lumen central venous catheter set unraveled.The device was required by an unknown patient for central venous access via the femoral vein.During the placement procedure, when the wire guide was removed from the introducer, it "broke".Unravelling of the wire guide was observed.No portion of the device was retained in the patient; however, a hematoma developed at the access site.Then access to the internal jugular vein on the opposite side of the body was obtained and the procedure was completed.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.It was noted that this failure was also observed in a competitor's device during insertion by a different clinician.It was also noted that due to hematoma formation "(b)(4)" was placed.Additional information regarding the event has been requested but is currently unavailable.
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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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Blank fields on this form indicate the information is unchanged, unknown or unavailable.Correction: d2, g4- these fields are unavailable for this device as it is not sold in the u.S.; however, this device meets the qualifications for a device that is same/similar to one that is sold in the u.S., thus prompting this report.Data for the like device is as follows: d2a- common name: foz catheter, intravascular, therapeutic, short-term less than 30 days d2b- product code: foz g4- pma/510(k) #: k081113.Investigation ¿ evaluation.Mackay base hospital informed cook that on 04feb2022 the guide wire in a c-uqlm-1001j-rsc-abrm-hc-rd-au (cook spectrum central venous catheter minocycline/rifampin antibiotic impregnated power injectable) from lot 13223095 had broken upon removal from introducer.The device was removed, and the access site was abandoned due to a hematoma development at the site.A new site was selected and another wire guide was used to complete the procedure.No unintended part of the wire guide remained inside the patient.There was no difficulty advancing the wire guide into the patient, but some resistance was felt with the dilator.The physician found this to be more of an issue in deeper cannulation.A review of the complaint history, device history record, instructions for use (ifu), and quality control, as well as a visual inspection was conducted during the investigation.Cook received one used guide wire.The guide wire was unraveled and elongated at 31.8cm from the proximal end.A kink/broken sections was noted at 21.8cm from the apex of the guide wires curve.The outer diameter of the wire guide is within specification.Additionally, a document-based investigation evaluation was performed.Cook concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook reviewed the device history record for lot 13223095 and records no relevant non-conformances.A search of subassembly lots found one related nonconformance for "coil stretched".The nonconforming device was scrapped prior to further processing.A database search for complaints found 2 additional complaints reported from the field.The first complaint, for unraveling wire, concluded component failure without design or manufacturing deficiency.The second complaint, for the sheath of the introducer needle being bent, does not relate to wire guide unraveling.There is no evidence of nonconforming material in house or in the field.Cook also reviewed product labeling.The product ifu, [c_t_ctulmabrmau_rev1] ¿cook spectrum central venous catheter minocycline/rifampin antibiotic impregnated power injectable,¿ provides the following information to the user related to the reported failure mode: precautions: do not cut, trim or modify catheter or components prior to placement or intraoperatively.Instructions for use: ¿4.Slide safe-t-j wire guide straightener (positioned on distal tip of wire guide) over ¿j¿ portion of wire guide.Pass straightened wire guide through needle; advance wire guide -10cm into vessel.If straight wire is used, always advance soft, flexible end through needle hub and into vessel.If resistance is encountered during wire guide insertion, do not force wire guide.Withdrawal of wire guide through needle should be avoided: breakage may result.8.Introduce the central venous catheter over wire guide.While maintaining wire guide position, advance catheter into vessel with a gentle twisting motion.¿ how supplied: ¿-upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, inspection of the returned device, and the results of the investigation, it was determined the cause of this event is related to component failure.The physician mentions that the difficulty is noticed during the femoral approach or obese patients with deep cannulation.It is possible that the difficulty with patient's anatomy is contributing to the guide wire damage.However, cook is unable to confirm this.As there is no evidence of manufacturing deficiencies, the cause of this event 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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