MAUDE Adverse Event Report: COOK INC COOK COPE-LOOP CATHETER

Model Number G14283

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Procode: lje, kob.Pma/510k #: k191498.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 during a nephrostomy malfunction replacement procedure, the tether of the cook cope-loop catheter was stuck in the patient body during the procedure.Additional information regarding event details, patient anatomy and outcome has been requested but is not available at this time.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary it was reported that during a nephrostomy malfunction replacement procedure, the tether of the cook cope-loop catheter was stuck in the patient¿s body during the procedure.Investigation - evaluation reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which caution, ¿do not forcefully advance any components during removal or replacement of the catheter.Carefully remove the components if any resistance is encountered.¿ the ifu also states, ¿important: to avoid breaking the catheter tether, unwind several centimeters of tether from the attached spool and gently straighten the catheter loop.¿gradually advance the catheter in the collecting system.If it becomes difficult to advance the catheter, insert the catheter introduction stiffening cannula over the wire guide and into the catheter.Some lubricant may be helpful.¿ based on the available information, cook has concluded that a cause for this event could not be established.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.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: COOK COPE-LOOP CATHETER
• 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: 12353130
• MDR Text Key: 267823957
• Report Number: 1820334-2021-02037
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00827002142831
• UDI-Public: (01)00827002142831(17)230612(10)13243585
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 11/19/2021

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: 06/12/2023
• Device Model Number: G14283
• Device Catalogue Number: 085110
• Device Lot Number: 13243585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 08/23/2021
• Supplement Dates Manufacturer Received: 11/19/2021
• Supplement Dates FDA Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other