MAUDE Adverse Event Report: COOK INC FIVE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 01/23/2021

Event Type  Injury  

Manufacturer Narrative

Suspect medical device: information provided by the customer identifies the device as a "pentalumen central venous catheter." gpn/rpn remain unknown at this time.(b)(6).Initial reporter occupation: product specialist.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that the wire of a pentalumen central venous catheter broke off in a patient's arm during insertion into the right subclavian.Once the vein was catheterized, the metal guide was inserted via the "syringe" using the seldinger technique.The "syringe" was then removed.The dilator was inserted via the metal guide with rotary movement in order to enter the skin and soft tissue without incident.When removing the dilator, the metal guide broke, with the distal part extracted together with the dilator.Most of the guide in the central vascular territory was unable to be removed.Once the approach was suspended, the physician proceeded to get access to the femoral central venous system on the first attempt with a different catheter.A vascular surgeon was referred to check on the patient the next day and initiate an anticoagulant therapy.It was reported by the customer that the entire procedure was reviewed with the operator and there was no error or step skipping during the procedure that could have caused this event.The procedure was completed with aseptic technique, guided by anatomy, with venous puncture on the first try.It was a clean procedure with no technical setbacks.The wire remains in the arm of the patient.Additional information regarding patient outcome has been requested, but is currently unavailable.

Manufacturer Narrative

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.

Event Description

No additional information regarding event details has been received since the previous medwatch report was sent.

Event Description

Additional information was received on 15feb2021.A resident at the user facility performed the procedure without applying excessive force or experiencing any difficulty.After the dilator was introduced, the wire guide "broke immediately" upon removal.The following day ((b)(6) 2021), the vascular surgeon removed the wire guide fragment from the patient without any complications.The patient did not experience any adverse effects as a result.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Additional information: b5, b7, d- product identifier, d1, d2, d4- product lot # (mdr), d4- expiration date, d4- rpn, d4- product lot #, d4- udi, g5, h4, h5, h6.Correction: b2.H6- patient code: no code available- the patient required an additional procedure to remove the separated fragment.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.

Manufacturer Narrative

Investigation - evaluation.On 26jan2021, (b)(4) notified cook of an incident where the wire guide from a five lumen polyurethane central venous catheter set (rpn: c-uqlm-1001j-rsc-rd) from lot 13100434 broke when attempting to remove the dilator.The part of the wire guide remaining in the patient was removed the following day without any complications.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 (mi), and quality control of the device was 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.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 design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhrs for the reported complaint device lot (13100434) and the related wire guide subassembly lot revealed no recorded non-conformances related to the failure mode.A database search identified one other event concerning the same failure mode that was reported by the same customer.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.Instructions for use (ifu) document c_t_rdulm_rev4 [uncoated and heparin-coated central venous catheters] is packaged with this device.The product ifu states the following in consideration of 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 product returned, and the results of our investigation, a definitive root cause for this event has been traced to a component failure unrelated to a deficiency in manufacturing/device design.It is possible that the wire guide was damaged from contact with a sharp object, such as the introducer needle or tortuous anatomy.When the dilator was advanced, it may have caught on a damaged section of the coil, leading to separation during withdrawal.This cannot be confirmed without additional information.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering 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.

• Brand Name: FIVE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11271989
• MDR Text Key: 230028568
• Report Number: 1820334-2021-00239
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K081113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/02/2021

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: 04/28/2023
• Device Model Number: N/A
• Device Catalogue Number: C-UQLM-1001J-RSC-RD
• Device Lot Number: 13100434
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 02/15/2021; 02/15/2021; 06/30/2021
• Supplement Dates FDA Received: 02/23/2021; 03/05/2021; 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 62 YR