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

Catalog Number C-UTLM-701J-RSC-ABRM-HC-RD

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2018

Event Type  malfunction  

Manufacturer Narrative

Brand name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set.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 a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter (cvc) was inserted successfully into the subclavian vein of the patient over the guidewire.The guidewire was then unable to be removed from the catheter.The healthcare professional removed both the wire and catheter together.A similar device was used in the same insertion site to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Upon further review, it was determined that this event is not reportable per 21cfr part 803.50 as it does not meet the criteria for a death, serious injury or reportable product malfunction.A review of reporting software revealed there are no previous incidents of difficult guide wire removal that lead to a death or serious injury.Additionally review of risk documentation indicated that this malfunction is not likely to cause serious injury if it were to reoccur.

Event Description

No additional patient/event details have been received since the previous medwatch report was sent.

Manufacturer Narrative

Device evaluation: the customer returned one used catheter for investigation.The endhole diameter of the catheter measured within specifications.The set comes with a.032¿ wire guide that the customer did not return.A test.032¿ wire guide was successfully passed through the catheter without difficulty.The reported failure could not be duplicated.Additionally, a document based investigation evaluation was performed.Investigation: a document-based investigation reviewed the following: quality control specifications, manufacturing instructions, complaint history and device history records.The relevant manufacturing documentation was reviewed.There are sufficient controls in place to ensure that non-conformances related to this failure mode will be identified prior to release.There is no evidence to suggest there are additional non-conforming devices in house or outside of manufacturer control.A review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.Review of component manufacturing records identified one relevant non-conformance (abrm coating on the inside of the shaft of the catheters) for the catheter component.The affected devices were scrapped.A complaint history search revealed that there were no other reported complaints for this lot number.Risk assessment determined that risk controls are in place to mitigate this failure mode and no further risk reduction activities are required for this failure mode.The appropriate personnel were notified, and we will continue to monitor for similar complaints.Conclusion: based on the information provided, examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.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 new event description information to report at this time.

• 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
• MDR Report Key: 7890505
• MDR Text Key: 120833099
• Report Number: 1820334-2018-02800
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002478299
• UDI-Public: (01)00827002478299(17)200524(10)8159631
• 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
• Report Date: 02/01/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2020
• Device Catalogue Number: C-UTLM-701J-RSC-ABRM-HC-RD
• Device Lot Number: 8159631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 09/19/2018
• Supplement Dates Manufacturer Received: 01/03/2019; 06/09/2020
• Supplement Dates FDA Received: 02/01/2019; 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1