MAUDE Adverse Event Report: COOK INC; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528); Unraveled Material (1664)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/11/2022

Event Type  Injury  

Manufacturer Narrative

Device name: cook spectrum minocycline/rifampin impregnated five lumen central venous catheter set.This device is not cleared for sale in the us, however; cook inc manufacturers a similar device with product code foz and pma/510(k)# - k081113.Customer (person): phone: (b)(6); postal code : (b)(6).Occupation: supply manager.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.

Event Description

It was reported that the wire guide in a cook spectrum minocycline/rifampin impregnated five lumen central venous catheter set unraveled.The device was inserted into the left internal jugular vein for central venous catheter placement.When the user attempted to remove the wire guide through the dilator, the wire guide unraveled and was retained in the patient.The patient was then transferred with the wire guide in situ to a tertiary hospital where the device was removed in an additional procedure.No other adverse effects were reported for this incident.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Additional information: b5, h6 - annex a.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.

Event Description

Additional information was received indicating that the wire guide separated and was retrieved in an additional procedure by a vascular surgeon.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation it was reported by a representative of mackay base hospital (australia) that the wire guide in a cook spectrum minocycline/rifampin impregnated five lumen central venous catheter set (rpn: c-uqlm-1001j-abrm-hc-rd-au; lot#: 14320570) unraveled.On (b)(6) 2022, the device was inserted into the left internal jugular vein for central venous catheter placement.When the user attempted to remove the wire guide through the dilator, the wire guide unraveled, separated, and was retained in the patient.The patient was then transferred with the wire guide in situ to a tertiary hospital where the device was removed in an additional procedure by a vascular surgeon.No additional adverse events were reported due to this occurrence.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 lot 14320570 records no relevant non-conformances.A search on the sub assembly lots (ic14182104, ic14211852, and ic14211854) found two like non-conformances.One was for flexibility incorrect, and the other was for weld not being caught.There are many procedures to identify these failures, and the non-conformances for both were scraped per cook procedures.A database search for complaints on the reported lot found one additional complaint reported from the field for guide wire fracturing from the same hospital and concluded component failure.There were no other complaints for this lot from other hospitals.The information provided upon review of device master record and device history record does not indicate the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Cook also reviewed product labeling.The product ifu, [c_t_ctulmabrm_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.-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.5.While maintaining wire guide position, withdraw needle and safe-t-j wire guide straightener.6.Enlarge puncture site with a number 11 scalpel blade, if required.If dilation is required, dilator can be advanced over wire guide and removed prior to insertion of central venous catheter¿¿ how supplied ¿-upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, no returned device, and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to the event.It is possible that the patient's tortuous or calcified anatomy could have caused difficulty when attempting to place or remove the device, but cook is unable to confirm this.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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 15266820
• MDR Text Key: 298335914
• Report Number: 1820334-2022-01371
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002531819
• UDI-Public: (01)00827002531819(17)231031(10)14320570
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: C-UQLM-1001J-ABRM-HC-RD-AU
• Device Lot Number: 14320570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/12/2022
• Initial Date FDA Received: 08/22/2022
• Supplement Dates Manufacturer Received: 08/21/2022; 11/16/2022
• Supplement Dates FDA Received: 08/23/2022; 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention