MAUDE Adverse Event Report: COOK INC PERCUTANEOUS MALECOT NEPHROSTOMY CATHETER SET; LJE CATHETER, NEPHROSTOMY

Catalog Number 082012-ET

Device Problem Unraveled Material (1664)

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

Event Date 06/28/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) number: k180029.Device is not approved for sale within the us but is similar to rpn: 082712.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 the wire guide of a percutaneous malecot nephrostomy catheter set unraveled during a nephrostomy.The user inserted the wire guide via another manufacturer's needle and advanced the catheter over it.The wire guide went into the superior calyx, so the user moved it to the renal pelvis/ureteropelvic junction.The user then attempted to adjust the wire guide but met resistance and was unable to more the wire guide.When the user removed the device, the wire guide unraveled.The device was removed from the patient, and the procedure was completed.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Event summary: it was reported that the wire guide of a percutaneous malecot nephrostomy catheter set unraveled during a nephrostomy.The user inserted the wire guide via another manufacturer's needle and advanced the catheter over it.The wire guide went into the superior calyx, so the user moved it to the renal pelvis/ureteropelvic junction.The user then attempted to adjust the wire guide but met resistance and was unable to more the wire guide.When the user removed the device, the wire guide unraveled.The device was removed from the patient, and the procedure was completed.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use, and quality control procedures and a visual inspection of the device were conducted during the investigation.The device was returned in an opened outer package.The wire guide was returned inside a non-cook needle.Approximately 4.5cm of wire guide was protruding the distal tip of the needle.At the hub end of the needle, the wire guide was uncoiled and stretched, and 5cm of the inner mandril was visible.The inner mandril was exposed at two places, and the lengths of the exposed portions were 1.5cm and 2cm.The approximate overall length of the wire guide was 109cm.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.There is no indication that a design or process related failure mode contributed to the reported event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The device is provided with instructions for use which state the following: "4.Pass the flexible end of the safe-t-j wire guide through the hub of the 18 gage needle cannula; insert the wire guide three more inches into the collecting system.Confirm the position fluoroscopically.Maintain the position of the wire guide as the needle cannula is withdrawn over it.Note: care must be exercised to avoid withdrawal of the the wire guide itself 7.Pass the malecot end of the catheter over the external end of the wie guide; gradually advance the catheter end well into the collecting system.Confirm the position fluoroscopically.After releasing the luer lock in order to open the malecot wings, carefully remove the blunt stylet." "8.While holding the shaft of the malecot catheter securely in position with one hand, withdraw the wire guide with the other.When the appropriate position of the malecot is assured by fluoroscopic visualization, remove the 22 gage needle." based on the available information, cook has concluded that a cause for the reported incident could not be determined.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: PERCUTANEOUS MALECOT NEPHROSTOMY CATHETER SET
• Type of Device: LJE CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12165732
• MDR Text Key: 261451999
• Report Number: 1820334-2021-01789
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 10827002191072
• UDI-Public: (01)10827002191072(17)240428(10)NS13925458
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/25/2021

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 Expiration Date: 04/28/2024
• Device Catalogue Number: 082012-ET
• Device Lot Number: NS13925458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Initial Date Manufacturer Received: 06/28/2021
• Initial Date FDA Received: 07/14/2021
• Supplement Dates Manufacturer Received: 08/03/2021
• Supplement Dates FDA Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 18G NEEDLE- HANACO; 18G NEEDLE- HANACO