MAUDE Adverse Event Report: COOK INC ULTRATHANE MULTIPURPOSE DRAINAGE SET; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 05/01/2023

Event Type  Injury  

Event Description

It was reported the catheter of an ultrathane multipurpose drainage set was difficult to remove from an unknown patient.The patient had the catheter placed with no issues in the bile duct for percutaneous transhepatic cholangio-drainage.After six days of placement, on (b)(6) 2023, the catheter was removed.Resistance was experienced and the patient "felt hurt" when removing the catheter.The user noted the suture was caught inside of the patient's body and was cut to remove the catheter.Part of the suture remained inside the patient's body.In addition, it is unknown what was connected to the drain fitting.The fitting was not securely attached at first inspection.No force was exerted on the catheter.The patient's physical activity level is unknown.Also, the device package was stored vertically and not damaged.Additional information regarding the event and patient outcome has been requested but is currently unavailable.

Manufacturer Narrative

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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

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

It was reported in additional information that there is no plan at this time to remove the retained suture.It is unknown if the patient had tortuous anatomy.Patient outcome is unknown.

Manufacturer Narrative

Investigation evaluation: it was reported by a representative of (b)(6) medical center (japan) that the suture from an ultrathane multipurpose drainage set (rpn: cldm-8.5-mh; lot#: 14948785) was retained in a patient.The device was placed in the bile duct during a percutaneous transhepatic cholangio drainage procedure.Six days later, on (b)(6) 2023, removal of the catheter was attempted; however, resistance was encountered which caused the patient pain.The user assumed the suture was ¿caught inside the patient¿s body¿, so the suture was cut.As a result, the suture was retained in the patient.No plans to remove the suture were reported.No other adverse events related to this event were reported.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, and instructions for use (ifu), as well as a visual inspection, functional test, and dimensional verification of the returned device, were conducted during the investigation.One used catheter was returned to cook for evaluation.Upon visual inspection, it was noted the suture string was still anchored at the mac-loc/ cap connection site.There was no evidence of suture string at the mac-loc adapter and/or distal end.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 14948785 and the related subassembly lots revealed no relevant non-conformances.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed product labeling.The ifu [t_multi2_rev1] ¿multipurpose drainage catheter¿ packaged with the device contains the following in relation 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.A tfe-coated wire guide must be used with ultrathane catheters.Instructions for use unlocking catheter loop for mac-loc locking loop mechanism: a.While stabilizing the mac-loc catheter hub assembly with one hand, position a small, blunt object (approximately the shape and size of a ball point pen or small forceps) into the mac-loc release notch.B.Pry upward until the locking cam lever is free.(fig.4) how supplied upon removal rom package, inspect the product to ensure no damage has occurred.The information provided upon review of the dmr, ifu, and associated dhr's suggests that the device was not manufactured out of 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, the root cause category would fall under cause traced to component failure, without any design or manufacturing issue.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 MULTIPURPOSE DRAINAGE SET
• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• 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: 16872618
• MDR Text Key: 314618440
• Report Number: 1820334-2023-00547
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002272989
• UDI-Public: (01)00827002272989(17)260210(10)14948785
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2023

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: CLDM-8.5-MH
• Device Lot Number: 14948785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2023
• Initial Date FDA Received: 05/04/2023
• Supplement Dates Manufacturer Received: 06/26/2023; 09/12/2023
• Supplement Dates FDA Received: 07/07/2023; 10/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2023
• 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