MAUDE Adverse Event Report: COOK INC UNKNOWN; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2021

Event Type  malfunction  

Manufacturer Narrative

Suspect medical device: unknown 16fr biliary drain or 14 fr biliary drain.Additional product codes: lje, fge.Occupation: unknown - cath lab personnel.Pma/510(k) #: k173035.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 female patient required an unknown 16 fr biliary drainage catheter for biliary drainage.Ten days after placement, upon trying to remove the drain, the "locking system" on the drain detached.The device was replaced with another similar device to successfully complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.A portion of the device was received by cook on 12jan2021 and showed a 14 fr catheter.Clarification regarding the identity of the device has been requested.

Manufacturer Narrative

Investigation-evaluation: (b)(6) medical center (united states) informed cook that on (b)(6) 2021 that an unknown 14fr biliary mac-loc locking loop drainage catheter separated when the drain was removed from the patient.The drainage tube was placed on (b)(6) 2020.When the user tried to remove the device, the hub separated a new device was placed to complete the procedure.A review of the complaint history, instructions for use (ifu), device history record (dhr), manufacturing instructions (mi), and quality control, as well as a visual inspection and dimensional verification of the returned device, was conducted during the investigation.One separated 14 fr.Ult was returned to cook for evaluation.Upon visual inspection, the mac-loc hub was noted to be separated from the tubing.A small "v" section is missing from the flare.The cap and mac-loc were separated.Relevant device components were measured and found to be within manufacturing tolerance.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file (dhf) showed that this device is both safe and effective for its intended use.While the specific lot number of the device was not provided, a search of lots sold to the customer three years prior to the event revealed one lot, 9064437, containing a 14 fr biliary drain.Additionally, the customer informed cook that they had 14 fr biliary drains in stock from lot 13082250.A review of the dhrs for both lots revealed no recorded non-conformances related to the reported failure mode.A database search did not identify any other events associated with either lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The ifu supplied with mac-loc drainage catheters instructs that the product should be inspected prior to use to ensure no damage has occurred.Appropriate measures have been taken to address this failure mode.A capa was previously opened to further investigate this failure mode with this device.Corrective actions have since been taken.Based on the information provided, inspection of the returned device, and the results of the investigation, a potential root cause for this event has been traced to a deficiency in manufacturing/quality control.As the lot number of the device is unknown, it is unknown if it was manufactured before or after the corrective actions.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: UNKNOWN
• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11211038
• MDR Text Key: 265822971
• Report Number: 1820334-2021-00143
• 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: 04/28/2021

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 04/27/2021
• Supplement Dates FDA Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1