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

Catalog Number ULT8.5-38-25-P-5S-CLDM-HC

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2023

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.D2a - common device name: additional names: gbo catheter, nephrostomy, general & plastic surgery; lje catheter, nephrostomy d2b - product code: additional product codes: gbo, lje e1 - customer (person): phone: (b)(6).E3 - occupation: radiologist.G4 ¿ 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.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.

Event Description

It was reported that an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter leaked.The device was required for percutaneous transhepatic cholangio drainage and was placed in the common bile duct (cbd).Two days after the procedure, the catheter was found leaking by an intensive care unit (icu) nurse.Subsequently, an additional procedure was required to remove and replace the catheter.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation.It was reported that an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter leaked.The device was required for percutaneous transhepatic cholangio drainage (ptcd) and was placed in the common bile duct (cbd).The second day after the procedure, the catheter was found leaking by an intensive care unit (icu) nurse.Subsequently, an additional procedure was required to remove and replace the catheter.No other adverse effects were reported due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures, as well as a visual inspection and functional test of the returned device, were conducted during the investigation.The ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was returned in a used condition.During table-top testing, using a syringe, hemostat, and water, it was confirmed the water was escaping between the cap and mac-loc adaptor.Before disassembling the device, a visual examination identified a fold in the flare to be present within the lumen of the mac-loc adaptor.Upon dissembling the cap from the mac-loc adaptor, it was confirmed the presence of a fold and tear in the flare.Additionally, thread marks were also present within the flare, near the top.Based on the evidence displayed regarding the flare, it is feasible to suggest the flare was too large, thus preventing proper seating between the cap and the mac-loc adaptor.The device was determined to have been manufactured out of specification.Additionally, the device master record (dmr) was reviewed and manufacturing instructions, quality control procedures, and specifications were identified.Sufficient controls are in place to detect this failure mode prior to release.A review of the device history record (dhr) showed one relevant nonconformance for "gap test failed".To date, a further search of our database records revealed no additional complaints have been received from the reported lot.Additional related lots manufactured in a similar time frame were reviewed.And no related complaints were found.Some of the related lots showed related nonconformances.All nonconforming product was scrapped prior to further processing of the orders.Cook did not find evidence of nonconforming material in house or in the field.Cook also reviewed product labeling.The current instructions for use [ifu__multi2_rev1] is packaged with this device.The product ifu states the following in consideration of 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.Based on the information provided, inspection of the returned device, and the results of the investigation, cook has concluded a manufacturing deficiency contributed to this incident.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: 18315195
• MDR Text Key: 330329574
• Report Number: 1820334-2023-01689
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 00827002097056
• UDI-Public: (01)00827002097056(17)260307(10)15256650
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

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 Catalogue Number: ULT8.5-38-25-P-5S-CLDM-HC
• Device Lot Number: 15256650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 03/26/2024
• Supplement Dates FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2023
• 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): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 69 KG