MAUDE Adverse Event Report: COOK INC ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number N/A

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/13/2023

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1: postal code: (b)(6).G4- 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.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 or that a death or serious injury occurred; nor is it admission 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

The suture thread of a ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was retained in a patient's body.On (b)(6) 2023 the patient had an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter placed in the bile duct.On (b)(6) 2023 during the removal of the catheter, the mac-loc portion of the device was unlocked, however, the suture was "severed" and remained in the patient's body.The patient is currently under observation.No other adverse effects were reported for this incident.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.This report includes information known at this time.A follow-up report will be submitted should additional, relevant information become available.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 or that a death or serious injury occurred; nor is it admission 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

Additional information was provided.As reported, the suture was cut when the catheter was removed due to adhesion with tissue.No health hazard to the patient was experienced.There are no plans to remove the suture.Removal will be considered if a strong inflammatory reaction occurs in the patient, but no inflammatory reaction has been confirmed at this time.

Manufacturer Narrative

D2a: gbo catheter, nephrostomy, general & plastic surgery; lje catheter, nephrostomy.D2b: gbo, lje.G4: k173035.Investigation ¿ evaluation: the suture thread of a ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was retained in a patient's body.On (b)(6) 2023 the patient had the catheter placed in the bile duct.On (b)(6) 2023 during the removal of the catheter, the mac-loc portion of the device was unlocked; however, the suture was cut by the user when the catheter was removed due to adhesion with tissue resulting in the suture being retained in the patient's body.There are no plans to remove the suture.Removal will be considered if a strong inflammatory reaction occurs in the patient, but no inflammatory reaction has been confirmed at this time.The patient is currently under observation.No other adverse effects were reported for this incident.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, specifications, manufacturing instructions (mi), and instructions for use (ifu), as well as a visual inspection of the returned device, were conducted during the investigation.One used catheter was returned to cook for evaluation.Upon visual inspection, it was noted that the end of the catheter at the point of separation was smooth.The mac-loc adaptor and the black suture string were not present.Dimensional analysis confirmed that the device and components were manufactured to the correct specifications and tolerances.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 dhrs for the reported complaint device lot and the related subassembly lots revealed relevant non-conformances which were scrapped prior to further processing.A database search did not identify any other events associated with the reported device lot.Cook also reviewed product labeling.The ifu [ifu__multi2_rev1] packaged with the device contains the following in relation to the reported failure mode: "precautions: patients with indwelling drainage catheters should be evaluated routinely to ensure continuous function of the catheter.How supplied: upon removal from package, inspect the product to ensure no damage has occurred." the information provided upon review of the dmr, dhr, ifu, and returned device suggests that the device was manufactured to specification, and that there are no nonconforming devices in house or out in the field.Based on the information provided, inspection of the returned device, and the results of the investigation, cook has concluded that the root cause category would fall under patient condition and procedural events contributed to this event.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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 DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Type of Device: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 17794702
• MDR Text Key: 324002430
• Report Number: 1820334-2023-01270
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2024
• 2 Devices were Involved in the Event: 1 2

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: ULT8.5-38-25-P-5S-CLDM-WF-HC
• Device Lot Number: 15373950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 09/21/2023
• Supplement Dates Manufacturer Received: 09/19/2023; 01/31/2024
• Supplement Dates FDA Received: 09/26/2023; 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other