MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problems Difficult to Remove (1528); Material Separation (1562); Separation Problem (4043)

Patient Problem Discomfort (2330)

Event Date 09/24/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: exempt.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 an unknown patient required placement of an ultrathane mac-loc locking loop multipurpose drainage catheter for an unknown procedure.During the procedure, the operator noted the "stent became detached and sheared" resulting in a "problematic procedure to remove".The patient experienced "increased radiation exposure and discomfort." no other adverse effects were reported for this incident.

Event Description

Additional information received 08jan2020 states the separations in the drain "were both deliberate." the operator "cut the drain to release the thread holding the retaining loop shape".The device was cut a second time to "shorten the drain while trying to get the wire back into the kidney to replace it." when the tip of the drain was in the renal pelvis, the stiffener was difficult to remove and "eventually snapped".

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Additional information - b5, d10, d11.D11 ¿ concomitant medical products: long stiff terumo wire.Correction - h6 - device codes.D10 ¿ product received on: 14nov2019.Investigation ¿ evaluation: a review of the complaint history, device history record, instructions for use (ifu), quality control, and specifications of the device, as well as a visual inspection, functional test, and dimensional verification, were conducted during the investigation.The complainant returned one catheter with the flexible stiffener inserted for investigation.Physical examination of the returned device showed no visible biomatter noted to either device.The mac-loc hub was returned with tubing exiting the fitting, and appeared to be cut.From the cut section, a segment was found with the distal end rough and sheared.The blue flexible stiffener was inserted in the catheter and separated as well.The proximal segment of the blue stiffener measured 33.1 cm from the hub to the separation.Six kinks on the blue flexible stiffener were noted.A section of the blue flexible stiffener was lodged in the distal separated segment of the catheter tubing.The distal separation point of the proximal segment was rough.Dimensions deemed relevant to the reported failure mode were analyzed and found that the device was manufactured within specification.Additionally, a document based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The risks associated with these devices are acceptable when weighed against the benefits.The device history record (dhr) for the complaint device lot and the tubing subassembly revealed no reported nonconformances.A database search revealed no other complaints have been reported for the device lot.There is no evidence the device was not manufactured to specification, or that there are nonconforming devices in house or out in the field.Cook also reviewed product labeling.The product instructions for use (ifu) does not have any information relevant to the reported failure mode.It¿s possible that inadequate flushing of the catheter could have caused biomatter to dry in the lumen of the catheter, obstructing the stiffener from being removed, but this cannot be confirmed at this time.Based on the information provided, inspection of returned product and the results of the investigation, it was concluded that a component failure without manufacturing or design issue contributed to the failure mode.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook 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.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9150957
• MDR Text Key: 176602335
• Report Number: 1820334-2019-02522
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002097650
• UDI-Public: (01)00827002097650(17)220709(10)9867203
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

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: 07/09/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-45-P-6S-CLM-RH
• Device Lot Number: 9867203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/03/2019
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1