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

Catalog Number UNKNOWN

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

As reported in the literature article, "urologist directed percutaneous nephrostomy tube placement," an insertion site infection occurred following the placement of a cook cope-loop nephrostomy set.The authors report the following: "a retrospective review of 100 consecutively placed nephrostomy tubes in 18 patients (53 women and 29 women) was done.All nephrostomy tubes were placed by house staff under the supervision of a single attending urologist.Varied nephrostomy tubes were used to gain experience with a range of drainage systems."patients were placed in the prone position with the knees flexed and all pressure points padded for nephrostomy tube insertion.Percutaneous access was routinely obtained with a 17.5 gauge angiomed 3-part initial puncture needle under ultrasonic guidance with a 3.5 mhz transducer.Preliminary ultrasonic imaging identified adjacent bowel and other internal organs.Knowledge of the approximate distance from the skin to the collecting system helped estimate needle puncture depth and, in addition, malrotated kidneys and renal hilar vessels were appreciated.Ultrasonic visualization of the puncture needle was maintained during insertion.Appropriate placement of the tip of the puncture needle also was confirmed by the efflux of urine and/or injection of radiocontrast material into the collecting system." "a floppy j-tipped guide wire was placed into the collecting system and down the ureter when possible.Fascial dilation developed an appropriately sized tract.The nephrostomy tube then was placed over the guide wire into the collecting system.Contrast medium was injected under fluoroscopic imaging to define the anatomy, confirm proper nephrostomy tube placement and exclude any associated injuries.All tubes were secured directly to the skin with 2-zero nylon sutures and simple 4x4 gauze dressings.An additional fixation point with tape was placed approximately 20cm.From the insertion site to help prevent twisting and kinking of the tube before connection to a closed gravity collection device.When cope tubes were used the tip was coiled in the renal pelvis with the pull-string.Balloon retention catheters were inflated with dilute contrast medium to confirm position.Immediate and delayed complications associated with nephrostomy tube placement were identified, and a detailed clinical assessment was done." ¿nephrostomy tubes (100) were placed in 29 women and 53 men.A range of different nephrostomy tube alternatives was used during the review period, reflecting a desire on our part to identify superior methods of nephrostomy access to limit procedure related and delayed drainage complications.We used 47 single j, 28 cook-cope, 11 rush nephrostomy, 9 foley urinary, 3 malecot and 1 rubber robinson urinary catheters and 1 argyle chest tube.¿ "complications related to the nephrostomy tubes were assessed as being either early (involved in catheter placement and becoming clinically apparent within 24 hours) or late (becoming apparent more than 24 hours after insertion).A total of 27 complications was noted in 14 patients." "ongoing peritubular leakage and infection occurred with a single j stent and a cope nephrostomy tube, respectively, when both had remained in place for longer than 1 week." cited: mahaffey, k.G., bolton, d.M., stoller, m.L.(1994).Urologist directed percutaneous nephrostomy tube placement.The journal of urology, 152, 1973-1976.Https://doi.Org/10.1016/s0022-5347(17)32282-6.

Manufacturer Narrative

Common name & product code: kob, catheter, suprapubic (and accessories).Pma/510(k) number: unavailable as the device lot number, rpn, and gpn are unknown.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Manufacturer Narrative

Event summary: as reported in the literature article, "urologist directed percutaneous nephrostomy tube placement," an insertion site infection occurred following the placement of a cook cope-loop nephrostomy set.Cited: mahaffey, k.G., bolton, d.M., stoller, m.L.(1994).Urologist directed percutaneous nephrostomy tube placement.The journal of urology, 152, 1973-1976.Https://doi.Org/10.1016/s0022-5347(17)32282-6.Investigation - evaluation: reviews of the quality control procedures and instructions for use of this device were conducted during the investigation.The device was not returned for investigation.As no lot information was provided, reviews of the complaint history and device history record could not be performed.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.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place assure functionality and device integrity prior to shipping.The device is provided with instructions for use which state, ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened and undamaged.Do not use the product if there is doubt as to whether the product is sterile.¿ the ifu further cautions the following: ¿this product contains natural rubber latex which may cause allergic reactions in some individuals.Periodic evaluation is advised; the catheter should not remain indwelling more than four weeks.This device is intended for use by physicians trained and experienced in percutaneous access and placement of drainage catheters.Standard techniques should be employed.Do not forcefully advance any components during removal or replacement of the catheter.Carefully remove the components if any resistance is encountered.¿ based on the available information and a clinical assessment of the event, cook has concluded that a cause for this event could not be established.Potential causes for the event, including patient factors, inadvertent user/procedural issues, and concomitant device use, could not be ruled out.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.

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 NEPHROSTOMY SET
• 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: 13738051
• MDR Text Key: 291955459
• Report Number: 1820334-2022-00387
• 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: 08/19/2022

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2022
• Initial Date FDA Received: 03/11/2022
• Supplement Dates Manufacturer Received: 07/26/2022
• Supplement Dates FDA Received: 08/19/2022
• 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): Other