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

Model Number N/A

Device Problem Unraveled Material (1664)

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

Event Date 08/11/2023

Event Type  malfunction  

Manufacturer Narrative

E1: customer (person).(b)(6).E3: occupation: regulatory affairs manager.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

It was reported the physician was unable to remove the wire guide from a cook ultrathane mac-loc locking loop multipurpose drainage catheter during a bilateral nephrostomy procedure.When attempting to remove the wire guide, after the catheter had been placed, the "moveable inner core came out" of the wire guide.The drainage catheter was removed from the patient and the wire guide was observed to be stuck inside 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 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

Per additional information, the procedure was completed by opening a new ultrathane mac-loc locking loop multipurpose drainage set.The wire guide was not manipulated nor withdrawn through the needle.It was noted the radiologist is very experienced.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation: it was reported the physician was unable to remove the wire guide from an ultrathane mac-loc locking loop multipurpose drainage set during a bilateral nephrostomy procedure.When attempting to remove the wire guide, after the catheter had been placed, the "moveable inner core came out" of the wire guide.The drainage catheter was removed from the patient and the wire guide was observed to be stuck inside the catheter.The procedure was completed by opening a new, like-device.It was noted the wire guide was not manipulated nor withdrawn through the needle.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), quality control, specifications, and instructions for use (ifu), as well as a visual inspection and dimensional verification of the returned device, were conducted during the investigation.One used wire guide stuck within the stiffening cannula was returned to cook for evaluation.Upon visual inspection, it was noted the mandril and safety wires were both protruding out from the distal portion of the wire guide.This suggests that the distal weld connection separated from the coil and safety wire resulting in coil elongation.Both the distal and proximal tip weld balls were present, suggesting that no piece of the outer wire guide coiling separated.Dimensional verification confirmed an o.D.Measurement of approximately.0382".At this time, there is no evidence that the device was manufactured out of specification.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 one related non-conformance in which seven devices were scrapped.A complaint history search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling.The ifu [t_multi2] supplied with the device states the following in consideration of the reported failure mode: 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.¿ based on the available information, inspection of the returned device, and the results of the investigation, cook has concluded that a component failure without design or manufacturing issue 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 toa 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, unavailable, or unchanged.Additional information: d9 correction: d2a, d2b, g4 d2a - additional common name: gbo catheter, nephrostomy, general & plastic surgery; lje catheter, nephrostomy d2b - additional product code: gbo; lje 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.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP 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: 17599305
• MDR Text Key: 322483114
• Report Number: 1820334-2023-01135
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002100497
• UDI-Public: (01)00827002100497(17)260119(10)15091069
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/11/2024
• 2 Devices were Involved in the Event: 1 2

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 Number: N/A
• Device Catalogue Number: CLM-8.5-RH-NPAS-NT
• Device Lot Number: 15091069
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 08/28/2023; 02/13/2024; 02/26/2024
• Supplement Dates FDA Received: 08/30/2023; 02/16/2024; 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2023
• 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