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	G51533
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer (person): phone: (b)(6).Occupation: product specialist.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that there was difficulty removing the wire guide during insertion of a five lumen polyurethane central venous catheter on (b)(6) 2020.Upon removal of the wire guide, it was found to be broken/unraveled.A male patient was admitted to the adult critical patient unit for acute respiratory failure associated with covid-19, and was reported to be in respiratory isolation.The indication for placement was administration of medication, hemoderivatives, and other treatment.A puncture was made in the subclavia under "sterile technique".The guide wire was inserted into the puncture site and followed by the catheter.Upon removal of the guide wire, it was found to be fractured.The entire device was removed from the patient and a different manufacturer's catheter was used to complete the procedure after performing another puncture.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Additional information: b5 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 or Problem Description
In additional information received on 24nov2020, it was reported that the needle was not withdrawn through the needle.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation - evaluation: it was reported that a wire guide from a five lumen polyurethane central venous catheter set (c-uqlm-1001j-rsc-rd) from lot 13117439 unraveled.This was noted upon its removal through the catheter.The catheter was removed and the procedure was restarted with a third-party device.Cook became aware of this event on 22oct2020 upon being notified by cencomex s.A.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 (13117439) and the related wire guide subassembly lots revealed no recorded non-conformances.A database search identified no other events associated with the reported device lot.Given this information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting that 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: 4¿.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 component failure without a deficiency in manufacturing/design.It is possible that the wire guide was damaged upon insertion through the needle, leading to its unraveling.However, this cannot be definitively 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.

• Brand Name: FIVE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET
• Common Device Name: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10802178
• Report Number: 1820334-2020-02031
• Device Sequence Number: 1137879
• Product Code: FOZ
• UDI-Device Identifier: 00827002515338
• UDI-Public: (01)00827002515338(17)230428(10)13117439
• Combination Product (Y/N): N
• PMA/510(K) Number: K081113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2023
• Device Model Number: G51533
• Device Catalogue Number: C-UQLM-1001J-RSC-RD
• Device Lot Number: 13117439
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 11/24/2020; 12/18/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 12/01/2020; 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1