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 Problem Difficult to Remove (1528)

Patient Problem Discomfort (2330)

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: stiff straight terumo radiofocus wire, cook bmc catheter, cook amplatz.Occupation: specialist radiographer.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 a male patient required placement of an ultrathane mac-loc locking loop multipurpose drainage catheter for a drainage catheter exchange procedure.After placement, the operator experienced difficulty advancing the wire "all the way through to the pigtail' because "there was a lot of waste within the catheter".Contrast was flushed through the device to "move any waste" to allow for the wire to get through.The physician inserted the wire again, and noticed there was a hole "within the catheter, just before the radiopaque marker near the pigtail".The catheter "had to be pulled out with the pigtail shape" when removed from the left ureter via a right sided ileal conduit.The patient experienced pain during removal.After removal of the device, the operator noticed "a split in the distal end, near to the pig tail." no other adverse effects were reported for this incident.

Manufacturer Narrative

Concomitant medical product received on: 19dec2020.Investigation ¿ evaluation.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, and quality control of the device, as well as a visual inspection and functional test were conducted during the investigation.The complainant returned one catheter to cook for investigation.Physical examination of the returned device showed: biomatter was present throughout the catheter and the catheter appeared to be ruptured at 37cm from the cap.The rupture was approximately 5mm in length, but no other damage was noted.No other dimensions were analyzed due to the returned condition of the device.At this time, there is no evidence suggesting the device was manufactured out of specification.Additionally, a document based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: warnings: ¿if a catheter has become malpositioned or if drainage ceases, the catheter should be promptly exchanged or removed.¿ precautions: ¿catheters should be irrigated on a routine basis to ensure function.Patients with indwelling drainage catheters should be evaluated routinely to ensure continuous function of the catheter.¿ the device history record (dhr) for the complaint lot and relevant subassemblies was reviewed and revealed no reported nonconformances relevant to the reported failure mode.A database search revealed no other complaints have been reported for the device lot.Due to this there is no evidence suggesting that nonconforming product from this lot exists in house or in the field.It is possible that inadequate flushing of the catheter for maintenance could have caused the occlusion, but at this time this cannot be confirmed.Based on the information provided, the examination of returned product and the results of the investigation, it was concluded that a component failure without design or manufacturing deficiency contributed to this incident.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.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: 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: 9340542
• MDR Text Key: 187458872
• Report Number: 1820334-2019-02919
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002097650
• UDI-Public: (01)00827002097650(17)220102(10)9415406
• 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: 01/14/2020

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: 01/02/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-45-P-6S-CLM-RH
• Device Lot Number: 9415406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 11/19/2019
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1