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

Model Number	G09502
Medical Device Problem Codes	Material Separation (1562); Obstruction of Flow (2423)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Additional 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 - procode: additional product codes: gbo, lje (b)(6).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 or Problem Description
It was reported that during an exchange an ultrathane mac-loc locking loop multipurpose drainage catheter was occluded.At this time, no adverse effects or additional procedures for the patient were reported due to this occurrence.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Additional 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.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 or Problem Description
Additional information was received.It is unknown how long the device was in place or where the device was placed.The device was not being exchanged due to blockage.It was confirmed that the patient did not experience any adverse effects or require any additional procedures.
Additional 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 or Problem Description
The device was returned for investigation on 16sep2024.The catheter shaft was noted to be separated.The mac-loc adaptor was missing and not returned with the catheter.The flare was also absent from the catheter body.The catheter shaft at the separation point exhibited jagged edges.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Correction- a2, a3.Investigation ¿ evaluation.It was reported that during an exchange an ultrathane mac-loc locking loop multipurpose drainage catheter was occluded.It is unknown how long the device was in place or where the device was placed.The device was not being exchanged due to blockage.The device was returned for investigation on 16sep2024.The catheter shaft was noted to be separated.The mac-loc adaptor was missing and not returned with the catheter.The flare was also absent from the catheter body.The catheter shaft at the separation point exhibited jagged edges.The patient did not experience any adverse effects due to this occurrence.Reviews of the documentation, including the complaint history, device history record, instruction for use (ifu), quality control procedures and specifications, as well as visual inspection returned product, were conducted during the investigation.The ultrathane mac-loc locking loop multipurpose drainage catheter was returned in a used and damaged state.A visual examination revealed ¿ballooning¿ of the shaft at approximately 9.6 cm from the distal tip.There was no evidence of shaft rupture.Additionally, dried biological matter was found on the catheter and sideports at the distal end.The mac-loc adaptor was missing and not returned with the catheter.The flare was also absent from the catheter body.The catheter shaft at the separation point exhibited jagged edges.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 there are adequate inspection steps currently in place to address this failure.A review of the device history record (dhr) for the device found no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that there was one other complaint associated with the final product lot number for the same device.Cook also reviewed product labeling: the instructions for use [t_multi2_rev1] is supplied with this lot, stating the following: warnings: ¿if a catheter has become mispositioned or if drainage ceases, the catheter should be promptly exchanged or removed.Precautions: ¿catheters should be irrigated on a routine basis to ensure function.¿patients with indwelling drainage catheters should be evaluated routinely to ensure continuous function of the catheter.Potential adverse events: ¿catheter occlusion/obstruction how supplied: ¿upon removal from package, inspect the product to ensure no damage has occurred.Evidence gathered upon review of the dmr, ifu, dhr and device evaluation 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 the reported event.The evidence suggests that excess force may have been applied during the catheter removal, leading to its separation.However, this cannot be conclusively verified per the risk assessment no further action is required.The appropriate personnel have been notified.Cook 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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Common Device Name: 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: 19991143
• Report Number: 1820334-2024-01090
• Device Sequence Number: 12907905
• Product Code: FGE
• UDI-Device Identifier: 00827002095021
• UDI-Public: (01)00827002095021(17)270202(10)15879729
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/22/2024

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
• Operator of Device: Health Professional
• Device Model Number: G09502
• Device Catalogue Number: ULT10.2-38-25-P-6S-CLM-RH
• Device Lot Number: 15879729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/02/2024
• Supplement Date Received by Manufacturer: 08/19/2024; 09/16/2024; 11/01/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 08/29/2024; 09/18/2024; 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male