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

Catalog Number 085110

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Pleural Effusion (2010)

Event Date 04/05/2012

Event Type  Injury  

Manufacturer Narrative

Literature article/journal; apr2012: gnessin, e., mandeville, j.A., handa, s.E., et.Al., 2012, the utility of noncontrast computed tomography in the prompt diagnosis of postoperative complications after percutaneous nephrolithotomy.Pma/510(k) number = 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 a total of 29 patients underwent a pnl procedure that resulted in thoracic complications.A total of two patients developed a hydro-pneumothorax but did not require treatment.A total of 25 patients developed a pleural effusion; 9 patients required thoracentesis, 1 patient required a thoracostomy.Two patients developed a calyceal-pleural fistula; one patient required stent placement.A section of the device did not remain inside the patient¿s body.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Additional information: b3 event description: it was reported that a total of 29 patients underwent a pnl procedure that resulted in thoracic complications.A total of two patients developed a hydro-pneumothorax but did not require treatment.A total of 25 patients developed a pleural effusion; 9 patients required thoracentesis, 1 patient required a thoracostomy.Two patients developed a calyceal-pleural fistula; one patient required stent placement.A section of the device did not remain inside the patient¿s body.Investigation - evaluation reviews of instructions for use (ifu) and quality control procedures were 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.There is no evidence to suggest the product was not made to specifications.The current quality control procedures were inspected instead of the controls at the time of the journal article for the sake of relevance.It was concluded that sufficient inspection activities are in place to identify device functionality prior to distribution.A review of the device history record could not be completed due to lack of lot information from the user facility.A review of complaint history records could not be completed due to lack of lot information from the user facility.The instructions for use (ifu) that is currently packaged with the device was reviewed for relevant information pertaining to the reported failure mode.Catheter placement: ¿introduce the 21-gauge needle below the twelfth rib, about five finger-breadths from the midline.Advance the needle in short steps toward the lower pole until the needle is seen moving with respiration.While the patient holds his or her breath, advance the needle no further than 3cm.If urine is not aspirated, repeat the process using a slightly different angle until a calyx is successfully punctured.¿ there is a limited availability of information given the date the study was published.Potential causes for the failure mode are patient factors, inadvertent user issues, and procedural issues.The current instructions for use that is packaged with the device was inspected and determined to contain adequate instructions for the application of the device and how to prevent misplacement/malposition of the device and the potential harms that could result from such an occurrence.Per the quality engineering risk assessment, no further action is required.We will continue to monitor for similar complaints.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: 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: 13800576
• MDR Text Key: 291845978
• Report Number: 1820334-2022-00410
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2022

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?: No
• 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: 02/21/2022
• Initial Date FDA Received: 03/17/2022
• Supplement Dates Manufacturer Received: 10/18/2022
• Supplement Dates FDA Received: 11/16/2022
• 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