MAUDE Adverse Event Report: COOK INC COOK COPE-LOOP CATHETER; LJE CATHETER, NEPHROSTOMY

Catalog Number 085110

Device Problem Material Separation (1562)

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

Event Date 06/30/2021

Event Type  Injury  

Manufacturer Narrative

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

As reported, a cook cope-loop catheter was placed in the patient (b)(6) 2021.At some point (date and time unknown), the luer lock separated from the nephrostomy tube.The catheter was removed on (b)(6) 2021 and a ureteral stent was placed to drain the kidneys instead of another nephrostomy tube.No additional patient consequences were reported.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.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

Additional information was received on 02jul2021: the tube was removed in the or intact.A ureteral stent had been placed to correct the obstruction as the nephrostomy tube had fallen out.

Event Description

There is no new patient or event information to report.

Manufacturer Narrative

Description of event: as reported, a cook cope-loop catheter was placed in the patient (b)(6) 2021.At some point (date and time unknown), the luer lock separated from the nephrostomy tube.The catheter was removed in the or intact on (b)(6) 2021 and a ureteral stent had been placed to correct the obstruction as the nephrostomy tube had fallen out.Investigation ¿ evaluation.A document based investigation was performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, and quality control data.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was made out of specification.A review of the device history record (dhr) or search for other complaints from the product lot could not be conducted due to lack of lot information from the user facility.The current ifu supplied with the nephrostomy set was reviewed and no information for end users related to this failure mode was identified.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The evidence from the complaint file and quality control documents indicates that the complaint device was manufactured to specification as well as other items in the lot or similar devices in the field or in house.A clinical review of the complaint concluded the cause of the event could likely be traced to device failure.However, there is limited information available at this time regarding patient anatomy/factors and/or user/procedural methods, such as inspection prior to placement or manipulation of the device during or after placement.Per the quality engineering risk assessment, a new risk assessment document was created in response to this complaint and no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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.

• Brand Name: COOK COPE-LOOP CATHETER
• Type of Device: LJE CATHETER, NEPHROSTOMY
• 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: 12202953
• MDR Text Key: 262665184
• Report Number: 1820334-2021-01842
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2022

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 Catalogue Number: 085110
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/21/2021
• Supplement Dates Manufacturer Received: 07/02/2021; 12/20/2021
• Supplement Dates FDA Received: 09/01/2021; 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 114 KG