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

Catalog Number UNKNOWN

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 12/01/1994

Event Type  malfunction  

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.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

As reported in the literature article, "urologist directed percutaneous nephrostomy tube placement," two cook cope-loop nephrostomy sets became dislodged after placement.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." "nephrostomy tube dislodgment occurred in 11 patients, including 6 single j catheters, 2 cope tubes, 2 foley catheters when the balloon retention chamber had been inflated with approximately 3ml nonionic radio-contrast material and in 1 argyle chest tube.Dislodgement appeared to be independent of patient weight, associated medical conditions or concurrent procedures.The skin sutures remained intact in all instances despite tube dislodgment." 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

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Additional information: b3 event description: as reported in the literature article, "urologist directed percutaneous nephrostomy tube placement," two cook cope-loop nephrostomy sets became dislodged after placement.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." "nephrostomy tube dislodgment occurred in 11 patients, including 6 single j catheters, 2 cope tubes, 2 foley catheters when the balloon retention chamber had been inflated with approximately 3ml nonionic radio-contrast material and in 1 argyle chest tube.Dislodgement appeared to be independent of patient weight, associated medical conditions or concurrent procedures.The skin sutures remained intact in all instances despite tube dislodgment." 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 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.It is unknown what ifu information was included at the time of this study and device use.The instructions for use (ifu) that is currently packaged with the device was reviewed for relevant information pertaining to the reported failure mode.The ifu contained the following information related to the failure mode of dislodgement.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/procedural issues, manufacturing issues, and/or device failure.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 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: 13737508
• MDR Text Key: 296078211
• Report Number: 1820334-2022-00385
• 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?: No
• Is this a Product Problem Report?: Yes
• 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: 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