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 Material Separation (1562)

Patient Problem Pneumothorax (2012)

Event Date 02/17/2020

Event Type  Injury  

Manufacturer Narrative

Initial reporter 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 an unknown patient required placement of an ultrathane mac-loc locking loop multipurpose drainage catheter for a nephrostomy tube procedure.During the procedure, the hub "detached".It was noted the "drain was looking like it was disintegrating".As the hub "fell off", the patient experienced a "larger" pneumothorax.No other adverse effects were reported for this incident.

Event Description

Additional information received 14may2020 clarified that the device was placed in the chest and was not a nephrostomy procedure.

Manufacturer Narrative

Additional method code: device not returned (4114).Investigation ¿ evaluation.A representative from (b)(6) hospital informed cook of an incident involving a ultrathane mac-loc locking loop multipurpose drainage catheter.On (b)(6) 2020 during a procedure the hub detached and was holding on by the string.No unintended section of the device remained inside the patient¿s body and the patient did not require additional procedures.However, due to this occurrence the patient's pneumothorax became larger in size.A review of the drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection of a photo provided by the customer, were conducted during the investigation.The complainant did not return the complaint device to cook for investigation.The customer provided an image of the device that failed.From the image, the hub was separated with the flare exposed.Additionally, a document based investigation evaluation was performed.The proper procedures are in place to identify and prevent this failure mode prior to device distribution.The risk specifications covering mac-loc drainage catheters include both hub separation and leakage as a potential failure mode.The identified risk controls include manufacturing quality control checks and process validation.The technical files covering mac-loc drainage catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.The ifu supplied with the mac-loc drainage catheters instruct that the product should be inspected prior to use to ensure no damage has occurred.A review of the device history record (dhr) could not be conducted due to lack of lot information from the user facility.A global sales shipment report was conducted from (b)(6) 2017 through (b)(6) 2020 for the complaint device, however, the lot was unable to be narrowed down.The information provided upon review of documentation and provided imaging suggests there is no evidence that the device was manufactured out of specification, or that there are nonconforming devices in house or out in the field.A capa was previously opened to investigate this issue; manufacturing-related root causes were identified, and corrective actions such as a gap gauge and retraining were performed.Based on the information provided, no inspection of returned product, and the results of the investigation, it was concluded that it is possible a manufacturing or quality control deficiency contributed to this incident as determined from the capa investigation.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: 9770238
• MDR Text Key: 192759865
• Report Number: 1820334-2020-00499
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-38-25-P-6S-CLM-RH
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/17/2020
• Initial Date FDA Received: 02/28/2020
• Supplement Dates Manufacturer Received: 05/14/2020
• Supplement Dates FDA Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1