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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

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COOK INC ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number N/A
Device Problem Difficult to Remove (1528)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/28/2023
Event Type  malfunction  
Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E3 - occupation: inventory.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.
 
Event Description
It was reported that the stiffener of an ultrathane mac-loc locking loop multipurpose drainage catheter became stuck and was unable to be removed during an unknown procedure on an unknown patient.It is currently not known if the patient experienced any additional procedures due to this occurrence.Additional information regarding event details and patient outcome has been requested but is currently unavailable.
 
Event Description
Additional information was provided.Blocked biliary ureteric drainage (bud) catheter exchange procedure was performed and placed in the kidney over a wire exchange.The issue occurred with the flexible stiffening cannula during the procedure in which the flexible stiffener became stuck inside the drainage catheter and was unable to be removed.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.This was the 4th occurrence for this device failure, each with a different unknown lot number.The other 3 instances are reported under patient identifier (b)(6).
 
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.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
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: d2b-product code: fge,gbo,lje and 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
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
 
Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation: it was reported that an ultrathane mac-loc locking loop multipurpose drainage catheter was placed over a wire for a blocked biliary ureteric drainage (bud) catheter exchange in the kidney.The flexible stiffener became stuck inside of the drainage catheter and was unable to be removed.Three previous instances of this failure mode, each with a different lot number, were reported by this customer and have been captured in mfg.Report reference #: 1820334-2023-01319.Reviews of the documentation, including the complaint history, device history record, instructions for use (ifu), manufacturing instructions, specifications, and quality control procedures, as well as a visual inspection and dimensional verification of the returned device, were conducted during the investigation.One used flexible stiffener, an amplatz wire guide, and drainage catheter were returned in a damaged condition.The flexible stiffener was returned twisted down onto the wire guide, lodging it inside.The stiffener exhibited material elongation and was accordioned in multiple locations throughout its length.The wire guide was able to be removed from the stiffener during the investigation.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 device history record (dhr) for the device and supplied lots found no relevant nonconformances that could have contributed to the reported failure.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed product labeling.The product ifu, [t_multi2_rev1] [multipurpose drainage catheter], provides the following information."precautions: when inserting a stiffening cannula into a catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of suture.How supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ evidence gathered upon review of the dmr, ifu, dhr, and returned device 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, examination of the returned product, and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to this incident.Per the risk assessment no further action is required.We 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.
 
Event Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
 
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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
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key17690804
MDR Text Key322738003
Report Number1820334-2023-01192
Device Sequence Number1
Product Code GBO
UDI-Device Identifier00827002097650
UDI-Public(01)00827002097650(17)260515(10)15437774
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 02/22/2024
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 NumberN/A
Device Catalogue NumberULT8.5-38-45-P-6S-CLM-RH
Device Lot Number15437774
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/29/2023
Initial Date FDA Received09/06/2023
Supplement Dates Manufacturer Received09/25/2023
12/21/2023
02/19/2024
Supplement Dates FDA Received09/29/2023
12/26/2023
02/22/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/15/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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