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

Model Number G47829

Device Problems Difficult to Remove (1528); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

Brand name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set.Customer (person): (b)(6).Investigation evaluation: it was reported that a needle from a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set (c-utlm-701j-rsc-abrm-hc-rd) from lot 9672911 was stuck and could not be withdrawn.Both the needle and wire guide were withdrawn, and a new set was opened to finish the procedure.The replacement wire guide later kinked during the procedure, but the procedure was completed regardless.Cook became aware of this event on 14aug2020 upon being notified by (b)(6) gen.Hosp.The patient reportedly experienced no adverse effects as a result of this incident.A review of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control, as well as a visual inspection and dimensional verification of the returned device, were conducted during the investigation.Two used wire guides were returned for evaluation, one inserted through a needle, and both within their holders.The wire inserted through the needle had several kinks near the distal tip.The distal weld connection is broken with slight coil elongation at the distal end.The other wire guide has a kink near the apex of the "j" curve.No weld breakage was noted on this wire guide.The outer diameters of both wires were measured at undamaged areas and found to be within specification.One of these wires was the complaint device, and the other was the replacement used in the procedure.Cook has concluded that the devices were manufactured to specification.Additionally, a document based investigation evaluation was performed.A review of the device master record found that proper procedures are in place to identify and prevent this failure mode prior to device distribution.A review of the design history file shows evidence of verifications in place to meet design requirements related to this failure mode.A review of the dhr for the device lot found no related nonconformance's.A review of the dhr for the wire guide subassembly lot revealed two related nonconformance's in which the devices affected were scrapped.No additional complaints for this device lot were found.There is no evidence to suggest there is any nonconforming product in house or out in the field.Additionally, a review of the product labeling for the device was completed.The instructions for use state the following instructions related to the reported failure mode: precautions: standard seldinger technique for placement for placement of percutaneous vascular access sheaths, catheters and wire guides should be employed during the placement of a central venous catheter.Instructions for use 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.How supplied: upon removal from package, inspect the product to ensure no damage has occurred.Based on the information provided, no inspection of the returned product, and the results of the investigation, a definitive cause for failure was traced to component failure unrelated to a manufacturing or design deficiency.It is likely the observed kinks on the returned devices contributed to the inability to withdraw it.It is possible that either forceful manipulation and/or tortuous patient anatomy contributed to the kinking/damage of the wires, but these possible causes cannot be confirmed without additional information.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.Cook will continue to monitor for similar complaints.

Event Description

It was reported that the guide wire of a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set became stuck in the needle upon withdrawal.Upon inspection of the complaint device on (b)(6) 2020, the wire was found to be elongated, thus prompting this report.On (b)(6) 2020, a (b)(6) female patient was undergoing a procedure in the right internal jugular vein.The physician advanced the wire guide into the patient through the needle.After placement of the cvc, the doctor attempted to remove the needle but found it to be stuck.Ultimately, the doctor was able to withdraw the wire and the needle together.A new device was used to complete the procedure.No adverse effects have been reported.

• Brand Name: COOK SPECTRUM
• Type of Device: FOZ 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: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 10680144
• MDR Text Key: 211476778
• Report Number: 1820334-2020-01853
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002478299
• UDI-Public: (01)00827002478299(17)220206(10)9672911
• Combination Product (y/n): Y
• PMA/PMN Number: K081113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2022
• Device Model Number: G47829
• Device Catalogue Number: C-UTLM-701J-RSC-ABRM-HC-RD
• Device Lot Number: 9672911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 58