MAUDE Adverse Event Report: COOK INC ULTRATHANE DAWSON-MUELLER 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 03/11/2021

Event Type  malfunction  

Manufacturer Narrative

Occupation: unknown.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 (b)(6) year-old male patient required an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter for drainage of pleural effusion.The device was placed under ultrasound guidance using seldinger technique and no issue was noted on insertion.Upon removal, the operator unlocked the mac-loc and loosened the suture, per protocol.The patient complained of some discomfort as the pigtail had to come through the ribcage.When the device was removed with mild resistance, the operator noted the pigtail did not completely uncurl and "appeared to be stuck not allowing the pigtail to straighten." nursing stall will continue to monitor patient condition and drainage site.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation.Helen beatty from sunshine coast university hospital in australia informed cook of an incident involving an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter from an unknown lot number.On (b)(6) 2021, the catheter was removed from the patient.The mac-loc lever was unlocked and the suture was loosened.During removal, the patient complained of discomfort.The nurses noticed that the pigtail loop did not fully straightened.The nurses were unable to straighten the loop but were able to remove the catheter from the patient successfully with mild discomfort to the patient.Once the catheter was out from the patient, the nurses still could not straighten the loop.The device was discarded.There were no issues during placement of the catheter.No unintended section of the device remained inside the patient¿s body, the patient did not require additional procedures due to this occurrence and there have been no adverse effects to the patient due to this occurrence.A review of the instructions for use (ifu), manufacturing instructions, and quality control of the device were conducted during the investigation.The complainant did not return the complaint device to cook for investigation.Due to this, no dimensional, visual, or functional verifications could be completed.The customer provided a photo of the complaint device.The photo has an 8.5fr mac-loc catheter with the lever up.The loop at the end has a half curve.The suture string is present both on the proximal and distal end.There appears to be no visual damage.Additionally, a document based investigation evaluation was performed.A device master record (dmr) review was performed, and device manufacturing instructions and quality control procedures associated with the complaint were identified.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device's design history files (dhf) were reviewed, and the risks associated with these devices are acceptable when weighed against the benefits.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: precautions: ¿- when inserting a stiffening cannula into a catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of suture.- traction on the locking suture, if present, should be sufficient to ensure adequate retention of the tip, but should not be overly tight.Verify catheter tip configuration by fluoroscopy.- it is recommended to use a wire guide when removing a locking loop catheter.¿ how supplied: "store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ the device history record (dhr) for could not be reviewed, due to lack of lot information.A sales report was conducted and cook was unable to narrow down the lot this complaint pertains to.There is no evidence suggesting nonconforming product exists in house or in the field.It is possible the suture became entangled, so the loop could not be fully released.Based on the information provided, the complaint device not being returned, and the results of the investigation, the cause was traced to a component failure without a manufacturing or design deficiency.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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ULTRATHANE DAWSON-MUELLER 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: 11596818
• MDR Text Key: 244422538
• Report Number: 1820334-2021-01039
• Device Sequence Number: 1
• Product Code: GBO
• 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: 06/16/2021

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 Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-5S-CLDM-HC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 03/31/2021
• Supplement Dates Manufacturer Received: 06/10/2021
• Supplement Dates FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR